DDrare: Database of Drug Development for Rare Diseases

6. パーキンソン病
［臨床試験数：2,123，薬物数：2,046（DrugBank：324），標的遺伝子数：183，標的パスウェイ数：198］

Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (11C)PE2I; (2-chloro-5-[11C]methoxy-N-(((3s,5s,7s)-3,5,7-trifluoroadamantan-1-yl)methyl) benzamide); (3beta, 5beta, 25R)-spirostan-3-ol; (3ß, 5ß, 25R)-spirostan-3-ol; (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol; (R)-troloxamide quinone; (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol; (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate; (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate; 0 mg tropicamide; 0.04 mg Lu AE04621; 0.08 mg Lu AE04621; 0.2 mg Lu AE04621; 0.3 mg tropicamide; 0.4 mg Lu AE04621; 0.6 mg Lu AE04621; 0.8 mg Lu AE04621; 0.9% sodium chloride; 0.9% sodium chloride (normal saline); 00000; 000000; 009-0; 009-1; 009-2; 009-3; 009-4; 009-5; 009-A0; 009-A1; 009-A2; 009-A3; 1 mg QD to 15 mg QD PF-06649751; 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study); 1 mg tropicamide; 1. Tesofensine (NS 2330); 1.0 mg Lu AE04621; 1.0 mg rasagiline mesylate; 1.2 mg Lu AE04621; 100; 11C-PBR28; 11C-PiB; 11C-Raclopride; 11C-methylreboxetine; 125; 13N-Ammonia; 15 mg QD PF-06649751; 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD; 15O H2O; 18-FDTBZ; 18F florbetaben; 18F- DTBZ; 18F-AV-133; 18F-AV-45; 18F-DOPA; 18F-DOPA PET; 18F-DTBZ; 18F-DTBZ AV-133; 18F-Dopa; 18F-Dopamne; 18F-FDG; 1[(6- Allyl- 8beta- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-; 1[(6- Allyl- 8beta- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea; 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-; 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea; 2 mg perampanel; 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide; 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE; 200 mg BIA 6-512; 207-3120; 240mg Amantadine HCl ER tablets; 25 mg BIA9 1067; 25 mg Ongentys; 25330; 3 mg QD to 15 mg QD PF-06649751; 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study); 3 mg tropicamide; 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate; 3-(3,4-Dihydroxyphenyl)-L-alanine; 320mg Amantadine HCl ER tablets; 4 mg perampanel; 50 mg BIA 9 1067; 50 mg Ongentys; 6abeta - apomorphine-10,11-diol hydrochloride hemihydrate; 6aß - apomorphine-10,11-diol hydrochloride hemihydrate; 7 mg QD to 15 mg QD PF-06649751; 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study); 7-beta-Hydroxyepiandrosterone; 7-beta-hydroxyepiandrosterone; 75; 8-OHdG; A-dopamine; AAV2-GDNF; AB1010; ABBV-0805; ABBV-951; ABT-SLV187; ACP-103; ACR325; AD-810N (zonisamide); ADS-5102; ADS-5102 (extended release amantadine HCl); ADX48621; AFFITOPE® PD01A; AFFITOPE® PD01A + Adjuvant; AFQ056; AFQ056 with L-dopa; AFQ065; AHA; AKST4290; AL; ALTROPANE®; AMANTADINE; AMANTADINE HYDROCHLORIDE; AMBROSAN 60mg Tablets; ANAVEX2-73; ANHYDROUS CARBIDOPA; AP; AP-CD/LD; AP09004; APL-130277; APO-go; APO-go®; APOKINON; APOKYN; APOMORPHINE HYDROCHLORIDE; APOMORPHINE HYDROCHLORIDE HEMIHYDRATE; APORON; AQW051; ARICEPT; AS2; ASyn Mab; AT 10; ATM FOG in PD; AV-101; AVALOX - 400 MG COMPRESSE RIVESTITE CON FILM 5 COMPRESSE IN BLISTER PP/AL; AVE8112; AVP-923; AVP-923-45; AZD3241; AZD3241 300 mg BID; AZD3241 600 mg BID; AZD3241 Alternative titration scheme with formulation 1 or 2; AZD3241 ER formulation 1; AZD3241 Extended release tablets 100 mg; AZD3241 Extended release tablets 25 mg; AZILECT; AZILECT 1 mg comprimidos; AZILECT®; Acamprosate; Accordion Pill Carbidopa/Levodopa; Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg; Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg; Accordion Pill? Carbidopa/Levodopa 50/400 mg; Accordion Pill? Carbidopa/Levodopa 50/500 mg; Accordion Pill™ Carbidopa/Levodopa; Accordion Pill™ Carbidopa/Levodopa 50/400 mg; Accordion Pill™ Carbidopa/Levodopa 50/500 mg; Acetate; Acetylcysteine; Active Investigational Treatment ENT-01; Active comparator; Active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.; Active drug: pimavanserin 17mg (2 strength tablets); Adjuvant without active component; Administration of stable isotope-labelled leucine-; Agomelatine; Agomelatine or PIacebo; Alanine; Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg); Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg); Allopurinol; Altropane; Amantadin-ratiopharm 100mg; Amantadine; Amantadine 300 mg; Amantadine HCl ER; Amantadine HCl Extended Release; Amantadine HCl Extended Release Capsule; Amantadine hydrochloride; Amantadine hydrochloride (HCl); Amantadine sulfate; Ambroxol; Ambroxol hydrochloride; Ammonia; Amoxicillin; Ampreloxetine; Ampreloxetine chydrochloride; Ampreloxetine hydrochloride; Ampyra; Ampyra first,; Anti-Parkinson medication; Antiparkinsonian Agent(s); Aplindore; Aplindore MR tablets; Apo-go; Apo-go®; Apokyn; Apomor; Apomorp; Apomorphine; Apomorphine 0.25% (2.5mg/ml); Apomorphine HCl injection; Apomorphine Hydrocloride; Apomorphine Hydrocloride Hemihydrate; Apomorphine Nasal Powder; Apomorphine hydrochloride; Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed; Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed; Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed; Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed; Apomorphine infusion; Aricept 5 mg-Filmtabletten; Aricept 5mg-Filmtabletten; Aripiprazole; Armodafinil; Artane; Atomoxetine; Atypical Antipsychotics; Autologous mesenchymal stem cells; Avalox; Azathioprine; Azilect; Azilect 1mg; Azilect®; B-CIT and SPECT imaging; B6, B12, L-methylfolate; BAVISANT HYDROCHLORIDE MONOHYDRATE; BEN-2001; BENSERAZIDE; BENSERAZIDE HYDROCHLORIDE; BF 2.649; BF 2.649 10 mg; BF 2.649 20 mg; BF 2.649 40 mg; BF 2.649 5 mg; BF2.649; BF2.649 (Pitolisant); BF2.649 (pitolisant); BI-Sifrol®; BIA; BIA 3-202; BIA 3-202 (200 mg); BIA 6-512; BIA 6-512 100 mg; BIA 6-512 100 mg dose; BIA 6-512 200 mg dose; BIA 6-512 25 mg; BIA 6-512 25 mg dose; BIA 6-512 400 mg; BIA 6-512 50 mg dose; BIA 9-1067; BIA 9-1067 (test); BIA 9-1067 15 mg; BIA 9-1067 25 mg; BIA 9-1067 30 mg; BIA 9-1067 5 mg; BIA 9-1067 micronized; BIA 9-1067 non-micronized; BIIB014; BIIB054; BIIB094; BOTOX; BOTULINUM TOXIN TYPE A; BROMOCRIPTINE; BTRX-246040; BTX-A; BYDUREON; Balance; Band; Bavisant; Bavisant dihydrochloride monohydrate; Beam; Bee venom; Behavioral: Assessment of cognition; Behavioral: Assessment of depression; Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors; Behavioral: Assessment of quality of life; Behavioral: Assessment of severity of ICD (impulse control disorders); Behavioral: Assessment of severity of Parkinson Disease; Behavioral: Attention Control; Behavioral: Augmented Reality Multi-Modal Training; Behavioral: BCI-FIT active querying; Behavioral: BCI-FIT adaptive signal modeling; Behavioral: BCI-FIT language modeling; Behavioral: BCI-FIT multi-modal access; Behavioral: Balance & Strengthening Exercises; Behavioral: Balance Training; Behavioral: Brisk walking and balance training; Behavioral: Building Better Caregivers Workshop; Behavioral: CBT and sleep hygiene; Behavioral: CO-OP treatment protocol; Behavioral: Cognitive and Behavioral experimental tasks; Behavioral: Combined balance and brisk walking training; Behavioral: Conservative Measures for Orthostatic Hypotension; Behavioral: Dexterity; Behavioral: Dual Task; Behavioral: ECOCAPTURE; Behavioral: Emotion Assessment; Behavioral: Exercise; Behavioral: Exercise only; Behavioral: Flexibility and strengthening exercise; Behavioral: Gait and balance; Behavioral: Healthy age-matched controls; Behavioral: ICM_APATHY_TASKS; Behavioral: Levodopa or acupuncture; Behavioral: Low-Impact Exercise Control; Behavioral: Memory; Behavioral: PAT sessions; Behavioral: Participant open-response writing; Behavioral: Participant self-assessment surveys; Behavioral: Pelvic floor muscle exercise-based behavioral therapy; Behavioral: Phonation; Behavioral: Physical Therapy; Behavioral: Resistance Training; Behavioral: Rest; Behavioral: Role of dopamine; Behavioral: Single Task; Behavioral: Strength training; Behavioral: Tai Chi; Behavioral: Traditional Multi-Modal Training; Behavioral: Upper limb exercise; Behavioral: balance training; Behavioral: exercise; Behavioral: exercise+multi-modal sensory feedback (MMSF); Behavioral: gait and balance training program; Behavioral: physical exam and UPDRS part III assessment; Behavioral: stretching; Benserazide; Benzofuran; Berachin; Best Medical Treatment; Best médical treatment; Betaquik MCT supplement; Better; Bisphosphonates; BoNT-A; Bone marrow derived mesenchymal stem cells; Botox; Botulinum Toxin; Botulinum Toxin Type A; Botulinum Toxin Type B; Botulinum Toxin Type B (Myobloc); Botulinum Toxin: Xeomin; Botulinum toxin; Botulinum toxin type A; Bromocriptine; Bromocriptine and other dopamine agonists; Bumetanide; Bumetanide white, oblong, scored tablet; Bupleurum+Ginkgo; Buspirone; Buspirone Hydrochloride; Buspirone hydrochloride; Butylphthalide; Bydureon; Bydureon 2 mg powder and solvent for prolonged-release suspension; Byetta; Byetta 5 micrograms; CABERGOLINA; CAPTURE; CARBIDOPA; CARBIDOPA (FU); CARBIDOPA ANIDRA; CARBIDOPA FU; CARBIDOPA INN; CARBIDOPA LEVODOPA; CARBIDOPA MONOHYDRATE; CARBODOPA LEVADOPA; CBD; CD; CD-LD CR; CD-LD IR; CDNF; CEP-1347; CEP-1347 10mg; CEP-1347 50mg; CEP1347; CEP1347 25mg; CERE-120; CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]); CERE-120: Adeno-Associated Virus Delivery of Neurturin; CERETEC (TM) Estabilizado; CIPRALEX; CJH1 (CLR4001); CLE; CLENBUTEROL HYDROCHLORIDE; CLOZAPINE; CO; COMTAN; COMTAN 200* 60 CPR 200 MG; COMTAN®; CP; CST-103; CST-139; CVD00118-E; CVL-751; CVN424 High Dose; CVN424 Low Dose; CVT-301; CVT-301 (Dose Level 1); CVT-301 (Dose Level 2); CVT-301 35mg; CVT-301 50mg; CVT-301 High Dose; CVT-301 Low Dose; CVT-301, LIP; CVXL-0107; CX-8998; CYMBALTA; Cabaser; Cabaseril; Cabaseril, 1,0 mg Tablette; Cabaseril, 2,0 mg Tablette; Cabergolina; Cabergoline; Caffeine; Caffeine 100-200 mg BID; Caffeine alkaloid; Calcium; Cannabidiol; Cannabidiol (CBD); Cannabis; Cannabis Oil; Cannabis, Medical; Capsaicin; Capsaicin vapor; Capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg); Carbidopa; Carbidopa 20 mg; Carbidopa 200mg oral dose; Carbidopa 27.5 mg; Carbidopa 65 mg capsule; Carbidopa Levodopa; Carbidopa Monohydrate; Carbidopa and Levodopa 25mg/100mg; Carbidopa and Levodopa Tablets, USP; Carbidopa and Levodopa tablets, USP; Carbidopa monohydrate; Carbidopa, levodopa, entacapone; Carbidopa- Levodopa; Carbidopa-4'-Monophosphate; Carbidopa-Levodopa; Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet; Carbidopa-levodopa; Carbidopa/Levodopa, immediate release; Carbidopa/Levodopa/Entacapone; Carbidopa/l-dopa; Carbidopa/l-dopa/entacapone; Carbidopa/levodopa; Carbidopa/levodopa/entacapone; Carbidopamonohydraat; Carbodopa/levadopa; Carbon; Carnosine; Carnosine supplementation; Carvedilol; Catapres ampoules; Catapressan; Ceftriaxone; Cerebral Dopamine Neurotrophic Factor; Ceretec; Champix; Chloride; Chocolate; Cipralex; Circadin; Circadin®; Citalopram; Citalopram 20mg; Clarithromycin; Clarithromycin (Not used as of 4/2020); Clarium 50 mg Retardtabletten; Clartihromycin, amoxicillin, and omeprazole; Clenbuterol; Clenbuterol HCl; Clonazepam; Clonidine; Clonidine hydrochloride; Clozapine; CoFactor; CoQ10; Cocoa; Coenzyme Q10; Coenzyme Q10 Nanodispersion (Nanoquinone); Coenzyme Q10 with vitamin E; Coenzyme q10; Cogane; Cogane™ (PYM50028); Cohort 1:Nilotinib Oral Capsules (150mg or 300mg); Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1); Combination Product: L-dopa 140 mg; Combination Product: L-dopa 35 mg; Combination Product: L-dopa 70mg; Combination Product: L-dopa 70mg/carbidopa 7mg; Combination Product: ND0612 Solution for SC infusion; Combination injection of EPO and G-CSF; Comparator: carbidopa; Comparator: levodopa; Comtan; Comtan®; ComtanÂ®; Comtess; Comtess®; Continuous Apomorphine infusion; Continuous Release Dopamine Agonists; Continuous Subcutaneous Lisuride Infusion; Continuous intrajejunal infusion of levodopa-carbidopa; Control; Controlled-release levodopa / carbidopa; Cord blood therapy; Cortef; Creatine; Cu(II)ATSM; CyberKnife; Cysteine; Cystoscopic injection of Botox into the urinary bladder; D-Serine; D-serine (~2g/day); DA-9701; DA-9805 45mg; DA-9805 90mg; DAAOI-P; DATSCAN; DC158AM; DCI; DCS; DEBRUMYL; DEFERIPRONE; DEXMEDETOMIDINA; DEXMEDETOMIDINE; DHA; DM; DM-1992; DMI; DNL151; DNL201; DNS-7801 (high dose); DNS-7801 (low-dose); DONEPEZIL; DOPS; DPA; DPA-714-PET/MRI; DUODOPA; DUODOPA®Intestinal Gel; DaTSCAN; DaTSCAN 74 MBq/ml solution for injection; DaTSCAN™; DaTSCAN™ Ioflupane (123I) Injection; DaTscan; Dacepton 5 mg/ml; Dacepton 5 mg/ml infuusioneste, liuos; Daily ingestion of Lactobacillus plantarum PS128; Darifenacin; Dark chocolate (85% cocoa); DatSCAN; Datscan; Deanol; Deanol pyroglutamate; Deferiprone; Deferiprone (Ferriprox); Deferiprone 20mg; Deferiprone 30mg; Deferiprone 600 mg delayed release tablet; Deferiprone DR; Desipramine; Desipramine (DMI); Desmopressin; Desmopressin Acetat; Desmotabs; Desmotabs® 0,2 mg Tabletten; Desmotabs® 0,2mg Tabletten; Determination of drug effects through amantadine cessation; Device: AHA Exergame System; Device: Abdominal compression; Device: ActiMyo recording; Device: Active tPCS; Device: Adaptor: Hakko Adaptor; Device: B-STN DBS; Device: Balance Training; Device: Balance Training with Nintendo Wii Fit; Device: CADD-Legacy ambulatory infusion pump; Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: Carbon Fiber Ankle Foot Orthosis (AFO); Device: Clonidine (Catapressan); Device: Deep Brain Stimulation; Device: Infusion Pump: CADD-Legacy® 1400 Pump; Device: Inspiratory Muscle Training; Device: J-tube; Device: Jejunal extension tube; Device: Kinetra and Soletra (neurostimulator, Medtronic); Device: Light box ( Litebook company); Device: Light box (Litebook company); Device: MS Band 2; Device: Magnetic Resonance Imaging; Device: Massage with a spiky ball; Device: NJ-Tube: Silicon ED Tube; Device: Nebulizer; Device: OCT - TCE; Device: PEG tube; Device: Percutaneous endoscopic gastrostomy tube; Device: Renishaw Drug Delivery System; Device: Resistive respiratory loads; Device: SPECT imaging; Device: Sham tPCS; Device: SpotOn balance glasses; Device: Stimulator OFF; Device: Stimulator ON; Device: active tDCS; Device: deep brain stimulation; Device: functional Magnetic Resonance Imaging; Device: jejunal extension tube (J-tube); Device: percutaneous endoscopic gastrostomy tube (PEG tube); Device: sham compression; Device: sham tDCS; Dexdor; Dexmedetomidina; Dexmedetomidine; Dexmedetomidine Hydrochloride Infusion; Dextromethorphan; Diagnostic Test: Auto-Assessment Manikins (SAM); Diagnostic Test: Barcelona test (BT); Diagnostic Test: Beam test to predict falls; Diagnostic Test: Beck Depression Inventory-II (BDI-II); Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau; Diagnostic Test: Flutemetamol F18 Injection; Diagnostic Test: Frontal assessment battery (FAB); Diagnostic Test: Global Deterioration Scale (GDS); Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and Ptau; Diagnostic Test: Measurement of serum level of anti-dementia drug; Diagnostic Test: Memory alteration test (M@T); Diagnostic Test: Mini Cognitive Examination (MCE); Diagnostic Test: Neuropsychological assessment; Diagnostic Test: Positive and Negative Affect Scale (PANAS); Diagnostic Test: Respiratory Muscle Strength; Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT); Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC); Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease; Diagnostic Test: [18F]-RO6958948; Different diets; Dihydroergotoxine Mesylate; Dipivefrin; Dipivefrine; Dipraglurant; Ditropan elixir; Docosahexaenoic Acid (DHA); Docosahexaenoic acid; Domperidone; Domperidone (drug); Dompéridone; Donepezil; Donepezil Sandoz; Donepezil hydrochloride; Dopamine; Dopamine Agent; Dopamine Agonists (pramipexole, ropirinole); Dopaminergic Agonist + Apomorphine; Dopaminergic Agonists; Doxepin; Doxepin and Zopiclone; Droxidopa; Droxidopa 100 MG [Northera]; Duloxetine; Duloxetine hydrochloride; Duodopa; Duodopa LD/CD 20/5 mg/mL; Duodopa gel intestinale; Duodopa intestinal gel; Duodopa intestinalgel; Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel; Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel; Dynacirc CR (Isradipine); E2007; EBIXA®; EGCG; ELC200; ELTOPRAZINE; EMD 128130; EMD128130; EN; ENA713; ENA713B; ENT-01; ENTACAPONA; ENTACAPONE; ENTACAPONE INN; EPI-589; EPI-743 200mg; EPI-743 400mg; ER CD-LD; ER tablet 100 mg AZD3241; ER tablet 25 mg AZD3241; ETHNODYNE VISIO; EXELON; EXENATIDE; Ebixa; Eliprodil; Elobixibat; Eltoprazine; Eltoprazine HCl; Eltoprazine Hydrochloride; Entacapon; Entacapona; Entacapone; Entacapone 400mg oral dose; Entacapone and carbidopa; Entecapone; Equal; Eradication of Helcobacter Pylori; Eradication therapy for H.pylori infection; Eradication therapy for Helicobacter pylori; Erythromycin; Erythropoietin; Erythropoietin human recombinant (EPOrh); Escitalopram; Escitalopram oxalate; Eszopiclone; Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below); Exametazime; Exelon; Exelon 4.6 mg/24 h transdermal patch; Exelon 9.5 mg/24 h transdermal patch; Exelon Patch; Exelon Patch (rivastigmine transdermal system); Exelon path transdermal; Exelon ®; Exenatide; Exenatide 10 micrograms; Exenatide 5 micrograms; Exenatide extended release 2mg (Bydureon); F-18 FPCIT; FB-101; FLECAINIDE ACETATE; FLORBETABEN (18F); FPF1100NW; FPFS-1169; Famotidine; Febuxostat; Ferriprox; Ferriprox 500 mg; Ferrprox (Deferiprone); Fesoterodine; Fetal porcine cells, Neurocell-PD; Filgrastim; Finamine tablets; Finasteride; Fipamezole; Fipamezole ODT; Fipamezole ODT Cohort 2; Fipamezole hydrochloride; Fipamezole hydrochloride 30 mg oral disintegrating tablets; Fipamezole hydrochloride 60 mg oral disintegrating tablets; Fipamezole hydrochloride 90 mg oral disintegrating tablets; Flecainide; Flecainide acetate; Flecainidum; Florbetapir F 18; Fludrocortisone; Flumazenil; Flutemetamol; Flutemetamol F18; Folic Acid, Vitamin B6, Vitamin B12; Folic acid; Foliglurax; Foliglurax 10 mg (treatment A); Foliglurax 30 mg (treatment B); Foscarbidopa; Foscarbidopa and Foslevodopa; Foslevodopa; G-CSF; GABAPENTIN; GABAPENTINA; GABAPENTINA KERN PHARMA; GENZ-682452; GM1 ganglioside; GM608; GOCOVRI; GPI 1485; GRF6021; GSH; GSK962040; GSK962040 (25 mg tablet); GZ/SAR402671; Gabapentin; Gabapentina; Galantamine; Ganoderma; Genetic: Optional pharmacogenetic assessment; Genz-682452-AU; Ghrelin; Ginkgo; Glial Cell Line-Derived Neurotrophic Factor (GDNF); Glial cell line-derived neurotrophic factor; Glucose; Glutathione; Glycerol; Glycerol Phenylbutyrate; Glycerol phenylbutyrate; Glycopyrrolate; Gold; Gold Nanocrystals; Grapefruit; Green Tea; Green Tea Polyphenols (EGCG/ECG); Group AD Anti-PD + Antidepressant; Group R Rasagiline; Group R+AD Rasagiline + Antidepressant; Guar gum; HB-adMSCs; HEC122505MsOH; HF0220; HP-3000 (ropinirole hydrochloride patch); HP-3000 placebo; HP-3000(ropinirole hydrochloride patch); Helicobacter pylori eradication therapy; Heptaminol; Heptaminol hydrochloride; Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.); Hericium erinaceus mycelium; Heshouwu; High Protein. T-Diet plus Range; High dose AFFITOPE® PD03A + Adjuvant; High dose ANAVEX2-73; Human Amniotic Epithelial Stem Cells; Human Stem Cells; Human neural stem cell; Hydrocortisone; Hydrocortisone cream; Hydrocortisone cream 1%; Hydrocortisone cream 10mg/g FNA Fagron; Hydrogen; Hydrolyzed guar gum; I 123; I-123; I-123-5-IA85380; I123; IBEROGAST; IOFLUPANE (123I); IPRONIAZID; IPT803; IPX054 100 mg; IPX054 150 mg; IPX054 200 mg; IPX054 250 mg; IPX054 300 mg; IPX066; IPX066 145 mg; IPX066 145 mg LD; IPX066 195 mg; IPX066 195 mg LD; IPX066 245 mg; IPX066 245 mg LD; IPX066 95 mg; IPX066 95 mg LD; IPX066-145; IPX066-195; IPX066-245; IPX066-95; IPX203; IPX203 140 mg; IPX203 180 mg; IPX203 210 mg; IPX203 270 mg; IPX203 280 mg; IPX203 350 mg; IPX203 ER CD-LD; IR CD-LD; IR CD-LD (carbidopa-levodopa) tablets; IR LD / CD; IR LD/CD; IRL752; IRL790; IRX4204; ISC-hpNSC; ISTRADEFYLLINE; ITI-214; IV Apomorphine; IV Levodopa; IZD174; Idebenone; Immediate Release carbidopa/levodopa 10/100 mg; Immediate Release carbidopa/levodopa 25/100 mg; Immediate release carbidopa/levodopa; Impact; Incobotulinum Toxin A; IncobotulinumtoxinA; IncobotulinumtoxinA (100 Units); IncobotulinumtoxinA (75 Units); Infudopa i.v.; Infudopa s.c.; Infusions of young plasma; Inhaled VR040; Injection of Umbilical cord derived MSCs; Injection of apomorphine; Injection of normal saline; Inosine; Intracerebral microinjections; Intranasal Insulin; Intranasal glutathione - (in)GSH; Intravenous Infusion; Intravenous Levodopa; Intravenous and Oral n-acetyl cysteine; Intravesical injection of Botulinum A toxin; Ioflupane 123I (DATSCAN®); Ioflupane I 123; Ioflupane [123 I]; Ioflupane [123I]; Ipratropium; Ipratropium bromide (drug); Iproniazid; Ips-nsc cells; Isicom; Isoflurane; Isradipine; Isradipine CR 10mg; Isradipine CR 20mg; Isradipine CR 5mg; Istradefylline; Istradefylline ( KW-6002); Istradefylline (KW-6002); Istradefylline 20 mg; Istradefylline 20 mg or 40 mg; Istradefylline 40 mg; JM; JM-010; JM-010 group A; JM-010 group B; JNJ-31001074; JNJ31-31001074; JP 1730; JP-1730/F01; JP-1730/F02; JP-1730/F03; JZP-110; K0706; KDT-3594; KM-819; KW-6002; KW-6002 (istradefylline); KW-6356; KW-6356 High Dose; KW-6356 Low Dose; KW-6356 Middle Dose; KW-6356 X Dose; KW-6356 Y Dose; KW-6500; Ketone Ester Elite endurance Nutrition Drink; Ketone ester drink; Kinoquinone (proposed); L-123 Ioflupane; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA; L-DOPS; L-Dopa; L-Dopa/ MODOPAR; L-dopa; L-methylfolate; L-tyrosine; LA; LCIG; LCIG (Duodopa); LD / BE; LD+DDCI; LD-DDCI; LD/CD; LEVODOPA; LEVODOPA (DC.IT) (FU); LEVODOPA / BENSERAZIDE 200 + 50 MG; LEVODOPA DC.IT FU; LEVODOPA INN; LEVODOPA/BENZERASIDE; LEVODOPA/CARBIDOPA; LISURIDE; LODALÈS®; LUBIPROSTONE; LY03003; LY03003 ( Rotigotine, extended-release microspheres); LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection); LY03003( the name of rotigotine); LY03003(Rotigotine,extended-release microspheres); LY03009 F1; LY03009 F2; LY03009 F3; LY03009 F4; LY300164; LY3154207; Lactobacillus casei DG (Enterolactis duo®); Lactobacillus plantarum; Lactobacillus plantarum PS128; Lactose; Leptin; Leucine; Levetiracetam; Levodopa; Levodopa (L-DOPA) + Standard care; Levodopa (L-dopa); Levodopa (delivered intravenously); Levodopa (drug), intraduodenal administration; Levodopa / Benserazid; Levodopa 100 mg / benserazide 25 mg; Levodopa 100 mg A CAP; Levodopa 125 mg A CAP; Levodopa 150 mg A CAP; Levodopa 25mg/100mg; Levodopa 75 mg A CAP; Levodopa Benserazide Madopar; Levodopa Benserazide Teva Italia; Levodopa CR (controlled release); Levodopa Cyclops; Levodopa MR; Levodopa acute challenge; Levodopa and Domperidone; Levodopa and carbidopa; Levodopa and carbidopa SC solution; Levodopa and carbidopa solution for SC administration; Levodopa and decarboxylase inhibitor; Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets; Levodopa carbidopa intestinal gel (LCIG); Levodopa dispersible; Levodopa infusion; Levodopa powder for inhalation; Levodopa tablet; Levodopa, carbidopa, ODM-104; Levodopa, carbidopa, entacapone; Levodopa, decarboxylase inhibitor and COMT inhibitor; Levodopa-4'-Monophosphate; Levodopa-Carbidopa; Levodopa-Carbidopa Intestinal Gel; Levodopa-Carbidopa Intestinal Gel (LCIG); Levodopa-Carbidopa Multilayer Extended Release Tablet; Levodopa-Carbidopa XL tablet (M); Levodopa-carbidopa; Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets; Levodopa-carbidopa Immediate Release (LC-IR) Tablets; Levodopa-carbidopa intestinal gel; Levodopa-carbidopa intestinal gel (LCIG); Levodopa-carbidopa-entacapone; Levodopa/Benzerazide; Levodopa/Carbidopa; Levodopa/Carbidopa (LD/CD); Levodopa/Carbidopa (Sinemet); Levodopa/Carbidopa Hydrate; Levodopa/Carbidopa Solution; Levodopa/Carbidopa(200mg/50mg); Levodopa/DDCI; Levodopa/benserazide; Levodopa/benserazide 100/25 mg; Levodopa/carbidopa; Levodopa/carbidopa 100/25; Levodopa/carbidopa hydrate; Levodopa/carbidopa solution; Levodopa/carbidopa/entacapone; Levodopa/dopa decarboxylase inhibitor; Liatermin; Liatermin (r-metHuGDNF); Lidocaine; Lingzhi (Ganoderma); Lipuro; Liquigen MCT oil; Liraglutide; Lisparin; Lisuride; Lisuride Hydrogenmaleate; Lisuride TTS; Lisuride TTS 10cm²; Lisuride TTS 20cm²; Lisuride Transdermal System; Lithium; Lixisenatide; Local Anesthesia (lidocaine hydrochloride); Local Trade Name, 2mg; Local Trade Name, 4mg; Local Trade Name, 8mg; Lodosyn®; Lovastatin; Low dose AFFITOPE® PD03A + Adjuvant; Lu 00-800; Lu AF28996; Lu AF82422; Lubiprostone; MANTADIX; MARS; MCT; ME2125 (safinamide mesilate); MEDI1341; MEMANTINE; MEMANTINE HYDROCHLORIDE; METHYLPHENIDATE HYDROCHLORIDE; MIRAPEXIN*30CPR 0,7MG; MK0657; MOCLOBEMIDE; MODAFINIL; MODOPAR; MOTILIUM; MOXIFLOXACINA CLORIDRATO; MSC; Madopar; Madopar 125 mg, orodispersible tablet; Madopar 200+50 mg; Madopar LT; Madopar® 125; Madopar® 250; Madopar® HBS; Madopar® HBS 125; Magnesium; Magnesium oxide; Maltodextrin; Mannitol; Mantadix; Masitinib; Masitinib mesylate; Mavoglurant; Melatonin; Melatonin PR; Melatonin(Circadin®); Melevodopa; Melevodopa and decarboxylase inhibitor; Melperon; Melperone; Melperone HCl; Memantin Orion; Memantine; Memantine (drug); Memantine hydrochloride; Mesdopetam; Mesdopetam (IRL790); Mesencephalic Neuronal Precursor Cells; Mesenchymal stem cells; Mestinon; Metabolic Cofactor Supplementation; Metformin; Methylphenidate; Methylphenidate (MPD); Methylprednisolone; Mg; Mid dose ANAVEX2-73; Midazolam; Midodrine; Minocycline; Minodronic acid; Mirabegron; Mirapex; Mirapex (pramipexole); Mirapex ER; Mirapex LA; Mirapexin; Mirapexin / Sifrol; Mirapexin extended release various strengths; Mirapexin/Sifrol; MitoQ; Moclobemide; Modafinil; Modafinil 50mg; Modal; Modiodal; Monoamine oxidase B inhibitors; Motilium; Moxifloxacin; Moxifloxacin infusion; Muscimol; Mémantine; N acetyl cysteine; N-0923; N-Acetylcysteine; N-acetylcysteine; N-acetylcysteine capsule; N.a.; N04BD02; NABILONE; NACOM 100; NACOM levodopa+cardidopa; NAL; NALOXONE HYDROCHLORIDE DIHYDRATE; NBTX-001; ND0611; ND0612; ND0612 (Levodopa/Carbidopa solution); ND1421; ND1587; ND1589; ND1590; ND1702; NERIXIA*IM EV 1F 25MG; NEUPRO; NEUPRO 2 mg/24 h parche transdérmico; NEUPRO 4 mg/24 h parche transdérmico; NEUPRO 6 mg/24 h parche transdérmico; NEUPRO 8 mg/24 h parche transdérmico; NEUPRO*28CER 2MG/24H; NEUPRO*28CER 4MG/24H; NEUPRO*28CER 6MG/24H; NEUPRO*28CER 8MG/24H; NEUPRO*7CER 4MG/24H; NEUPRO*7CER 6MG/24H; NEUPRO*7CER 8MG/24H; NEUROBLOC; NICOTINAMIDE; NICOTINE; NLY01; NMDA; NPC transplantation; NR2B NMDA Antagonist CP-101,606 (traxoprodil); NS 2330; NS2330; NT 101; NTCELL Implantation; NW-1015; NW-1015E, EMD 1195686, MSC2191632B; NYX-458; Nabilone; Nabilone 0.25 mg; Nacom; Nacom 100; Nalmefene; Naloxone; Naloxone Hydrochloride Dihydrate; Naltrexone; Nardil; Nebicapone; Nelotanserin; Neridronic Acid; Neridronic acid; Neu-120; Neupro; Neupro (Reference); Neupro 2 mg/24 h transdermal patch; Neupro 2mg/24 h transdermal patch; Neupro 2mg/24h transdermal patch; Neupro 4 mg/24 h transdermal patch; Neupro 4Mg/24Hr Transdermal Patch; Neupro 4mg/24 h transdermal patch; Neupro 4mg/24h transdermal patch; Neupro 6 mg/24 h transdermal patch; Neupro 6mg/24 h transdermal patch; Neupro 6mg/24h transdermal patch; Neupro 8 mg/24 h transdermal patch; Neupro 8mg/24h transdermal patch; Neupro®; Neuraceq; NeuroEPO; Neurobloc; Neurohormonal mechanisms; Neurpro; Niacin; Niacinamide; Nicorette 10mg/ 16 h; Nicorette 15 mg/ 16 h; Nicorette 5 mg/ 16 h; Nicotinamide; Nicotinamide Riboside; Nicotinamide riboside; Nicotine; Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY); Nicotine gum; Nicotine patch; Nicotine transdermal patch; Nicotinell; Nicotinell 17,5 mg/24-Stunden-Pflaster; Nicotinell 35 mg/24-Stunden-Pflaster; Nilotinib; Nilotinib 150mg oral capsule [Tasigna]; Nilotinib 300mg oral capsule [Tasigna]; Nitrogen; Normal Saline; Northera; Nortriptyline; Nortriptyline hydrochloride; Null; OC oral solution treatment A; OC oral solution treatment B; OC oral solution treatment C; OC oral solution treatment D; ODM-101; ODM-101 105mg Carbidopa; ODM-101 65mg Carbidopa; ODM-104; ONO-2160/CD; ONO-2370; ONO-2506PO; OPC; OSU 6162 similar to (-)-OSU 6162; OSU6162 similar to (-)-OSU 6162; OTHER NERVOUS SYSTEM DRUGS; OXB-102; OXN 10 mg / 5 mg PR; OXN 20 mg / 10 mg PR; OXN 5 mg/2.5 mg PR; OXYCODONE HYDROCHLORIDE; OXYTOCIN SYNTHETIC; Omeprazole; Onabotulinumtoxin A Injection; OnabotulinumtoxinA; Ondansetron; Ondansetron 8 mg film-coated tablets; Ondansetron hydrochloride dihydrate; Ongentys; Opicapone; Opicapone (OPC); Optimal drug therapy; Optimized antiparkinsonian treatment; Oral Levodopa/Carbidopa; Oral escitalopram; Oral levodopa and carbidopa; Orally disintegrating selegiline (Zelapar); Other Parkinson's Disease treatments; Other: Balance; Other: Balance Training; Other: Balance exercise; Other: Berg Balance Scale; Other: Best Medical Treatment; Other: Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease; Other: Control; Other: Controlled environment tests (series of tasks of everyday life); Other: Controls Primary Cervical Dystonia (Trihexyphenidyl); Other: DYT 1 Dystonia; Other: DYT 1 Dystonia (Healthy Control); Other: Data Capture; Other: Diary completion; Other: Endurance; Other: Evaluation by Investigator; Other: Event-related evoked potential using electroencephalography (EEG).; Other: Four Square Step Test; Other: Functional Reach Test; Other: Functional mobility; Other: Gait and balance group training; Other: High intensity exercise and balance training; Other: Hoehn and Yahr Scale; Other: Imitation Surgical Procedure (ISP); Other: Lower Limb Strength; Other: MIBG label with I123 or I124; Other: MP+DDCI; Other: MP-Equivalent; Other: MP-Low; Other: MRI; Other: Mobile platform exercise; Other: Motor Assessments before taking regular PD treatment; Other: Motor Assessments on regular PD treatment; Other: Multidisciplinary intensive rehabilitation treatment; Other: Music; Other: Neupro 4 mg / 24 Hr. Transdermal Patch; Other: Non-Motor Symptoms; Other: Nordic walking (only osteoporosis group); Other: Observational cohort; Other: Optional Blood-Oxygen-level Dependent functionalMRI; Other: PD exercise intervention; Other: PD vitamin + exercise; Other: Parkinson mPower mobile application; Other: Physical Function Performance Test; Other: Physical Therapy; Other: Pittsburgh Compound B [11C]-PIB; Other: Questionnaires; Other: Recommendation with regard to nutrition; Other: Rhythmic Auditory Stimulation (RAS); Other: Rhythmic Balance-Movement Training (rBMT); Other: Rotigotine; Other: Saline; Other: Screening to prevent falls; Other: Sham Surgery; Other: Sham group; Other: Smartphone-based balance exercises; Other: Specific SL-therapy; Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS; Other: Stool Sample; Other: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale; Other: Timed Up and Go Test; Other: Trunk Impairment Scale; Other: Unified Parkinson's Disease Rating Scale; Other: Usual care arm exercise; Other: Usual drug treatment of Parkinson's disease; Other: Voluntary cough test; Other: [11C]donepezil PET; Other: collection of CSF, blood, urine, saliva; Other: fog; Other: hemicellulose crystalline; Other: t-DCS group; Other: the timed 360° turn test; Other: tyramine; Over-encapsulated Entacapone Tablets; Over-encapsulated Modafinil; Oxaloacetate (OAA); Oxybate; Oxybuprocaine; Oxybutynin; Oxybutynin and darifenacin; Oxybutynin hydrochloride; Oxycodone; Oxycodone Hydrochloride; Oxycodone hydrochloride; Oxycodone/Naloxone Prolonged Release tablets; Oxycodone/naloxone prolonged release tablets 10 mg /5 mg; Oxycodone/naloxone prolonged release tablets 20 mg /10 mg; Oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg; Oxygen; Oxytocin; P2B001; P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),; P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),; PARCOPA; PAT; PBF-509; PD patients H&Y=1.5-2 Medications OFF; PD patients H&Y=1.5-2 Medications ON; PD patients H&Y=3 Medications OFF; PD patients H&Y=3 Medications ON; PD vitamin supplementation; PEG; PERGOLIDE; PET; PF-06412562; PF-06649751; PF-06649751 - 15mg; PF-06649751 - 1mg; PF-06649751 - 5mg; PF-06649751 high dose (15 mg QD); PF-06649751 low dose (1 mg QD); PF-06649751 middle dose 1 (3 mg QD); PF-06649751 middle dose 2 (7 mg QD); PF-06669571; PK-Merz; PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj; PR Oxycodone; PR001A; PRAMIPEXOLE; PRAMIPEXOLE DIHYDROCHLORIDE; PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; PRIM-DJ2727; PROPOFOL; PROSCAR*30CPR RIV 5MG; PRX002; PRX002, ELT2, anti-alpha-synuclein monoclonal antibody; PT320 2.0 mg; PT320 2.5 mg; PXT002331; PXT002331 - 20mg; PXT002331 - dose 1; PXT002331 - dose 2; PYM50028; PYRIDOSTIGMINE BROMIDE; Paracetamol; Parapres; Parcopa; Pardaprunox; Pardoprunox; Pardoprunox hydrochloride; Paroxetine; Part 1, JM-010 component Group A; Part 1, JM-010 component Group B; Part 1, JM-010 component Group C; Part 2, JM-010 combination Group A; Part 2, JM-010 combination Group B; Part 2, JM-010 component Group C; Perampanel; Pergolide; Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid; Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid; PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid; PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid; Phenlarmide Tablets; Phenylbutyrate; Piclozotan; Pilocarpine; Pimavanserin; Pimavanserin (ACP-103); Pimavanserin tartrate; Pimavanserin tartrate (ACP-103); Pioglitazone; Piribedil; Piribedil (Clarium); Pitolisant; Pittsburgh Compound B; Placebo; Plantago ovata husk; Posiphen; Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin); Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin); Pramipexol; Pramipexol Extended Release; Pramipexol Immediate Release; Pramipexole; Pramipexole 0.125 mg tablets; Pramipexole 0.5 mg tablets; Pramipexole ER; Pramipexole Extended Release; Pramipexole IR; Pramipexole Immediate Release; Pramipexole SR; Pramipexole dihydrochloride; Pramipexole dihydrochloride extended-release tablets; Pramipexole dihydrochloride monohydrate; Pramipexole dihydrochloride monohydrate extended release; Pramipexole extended release tablet; Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole); Pramipexole immediate release; Pramipexole immediate release tablet; Pramipexole or ropinirole; Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride); Prednisone; Preladenant; Preladenant 10 mg tablet; Preladenant 2 mg tablet; Preladenant 5 mg tablet; Premarin ®; Pridia (Donepezil Hydrochloride) 5mg; Pridia 10mg; Pridia 5mg; Pridopidine; Primary Cervical Dystonia (Trihexyphenidyl); Primavanserin tartrate; Prior Donepezil 5mg; Prior Donzepezil 10mg; ProSavin; Probiotic; Probiotic Capsule; Probiotics with prebiotic; Procedure: Biofluid samplings; Procedure: Blood analysis; Procedure: Cardiac monitoring; Procedure: DATscan and SPECT imaging; Procedure: Electroacupuncture; Procedure: Exergame; Procedure: Fluoroscopic swallow evaluation; Procedure: Home based balance training; Procedure: Lumbar Puncture; Procedure: MEG; Procedure: Motion Analysis; Procedure: PET/CT; Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J); Procedure: Sedation with IV propofol; Procedure: Sham Surgery; Procedure: Static, dynamic and functional balance exercises; Procedure: Static, dynamic and functional balance exercises with dual task; Procedure: Tissue samplings; Procedure: Umbilical cord blood therapy; Procedure: [123I]-IBZM imaging; Procedure: [123I]beta-CIT and SPECT imaging; Procedure: [123I]ß-CIT and SPECT imaging; Procedure: blood draw; Procedure: embryonic dopamine cell implant surgery; Procedure: physical exam and UPDRS part III assessment; Prolonged release tablet; Prolopa®; Propanoic acid; Propofol; Propofol-Lipuro; Propranolol; Propranolol HCl CF 40 mg tablet; Pyridostigmine; Pyridostigmine bromide; Quetiapine; R-(-)-1-(benzofuran-2-yl)-2-propylaminopentane hydrochloride; R-metHuGDNF; RAAV-GAD; RAS; RASAGILINA MESILATO; RASAGILINE; RASAGILINE MESILATE; RASAGILINE MESYLATE; REQUIP; REQUIP 21 CPR 0,25 MG; REQUIP 21 CPR 0,5 MG; REQUIP 21 CPR 1 MG; REQUIP 21 CPR 2 MG; REQUIP*21CPR 0,25MG; REQUIP*21CPR 0,5MG; REQUIP*21CPR 1MG; REQUIP*21CPR 5MG; REQUIP*28CPR 8MG R.P.; REQUIP-LP; REQUIP-MODUTAB , 2mg; REQUIP-MODUTAB , 4mg; REQUIP-MODUTAB , 8mg; REQUIP-MODUTAB, 2mg; REQUIP-MODUTAB, 4mg; REQUIP-MODUTAB, 8mg; RIV-TDS 13.3 mg/24 h; RM-131; RO; RO7046015; ROP; ROP+L-Dopa; ROPINIROLE; ROTIGOTINA; ROTIGOTINE; ROZEREM; RQ-00000010; RVG 08740; RVG 55618; RVT-101 35 mg; Raclopride; Racol; Radiation: Fluoroscopy; Radiation: H215O PET; Radiation: PET with the tracer 11C-PE2I; Radiation: PET with the tracer 18F-DPA-714; Radiation: Radiosurgical thalamotomy; Radiation: Videofluoroscopic swallow evaluation; Radiation: [18-Fluorine] Flubatine PET Scan; Ramelteon; Rasagilin; Rasagilina; Rasagilina mesilato; Rasagilina mesilato (12 weeks); Rasagiline; Rasagiline 1 mg capsule; Rasagiline 1mg tablet; Rasagiline 2 mg tablet; Rasagiline Mesylate; Rasagiline mesilate; Rasagiline mesylate; Rasagiline mesylate 1.0 mg; Rasagiline mesylate plus Mirapex; Rasagiline mesylate with Levodopa; Rasagiline mesylate with Requip; Rasagiline tablets; ReQuip CR; ReQuip PR; Recombinant human Cerebral Dopamine Neurotrophic Factor; Recombinant-methionyl human glial cell line-derived neurotrophic factor; Reduced Glutathione; Reduced Glutathione 100mg; Reduced Glutathione 200mg; Regular Novolin R; Remifentanil; Remifentanyl; Reminyl; Reminyl Retard; Repaglinide; Requip; Requip Modutab, 2mg; Requip Modutab, 4mg; Requip Modutab, 8mg; Requip PR; Requip XL prolonged-release; Requip prolonged release; Requip-Modutab; Resistant maltodextrin; Resistant starch; Restex Tabletten; Rifampicin; Rifampin; Rifampin 300mg BID + istradefylline 40mg Day 8 only; Rifaximin; Rifaximin 550 MG; Ritalin; Rivastigmin Luye Transdermal Patches - 4.6mg/24h; Rivastigmine; Rivastigmine CF; Rivastigmine Luye Transdermal Patch- 9.5mg/24h; Rivastigmine Patch 9.5 cm2; Rivastigmine Transdermal System; Rivastigmine capsule; Rivastigmine transdermal patch; Rivastigmine transdermal system 13.3 mg/24 h; Ropinirole; Ropinirole (as hydrochloride); Ropinirole CR 2mg tablet; Ropinirole CR 8mg tablet; Ropinirole Hydrochloride; Ropinirole IR; Ropinirole IR Tablets; Ropinirole Implant; Ropinirole PR; Ropinirole PR, 2mg; Ropinirole PR/XR; Ropinirole PR/XR Tablets; Ropinirole PR/XR tablets; Ropinirole Prolonged release; Ropinirole XL; Ropinirole XL (formerly CR); Ropinirole controlled-release (REQUIP CR) for RLS; Ropinirole hydrochloride; Ropinirole hydrochloride extended-release tablet; Ropinirole hydrochloride extended-release tablet placebo; Ropinirole hydrochloride prolonged release; Ropinirole immediate release; Ropinirole monotherapy; Ropinirole oral product; Ropinirole prolonged release; Ropinirole prolonged release/extended release(PR/XR); Ropinirole/L-dopa; Rosuvastatin; Rotigotin; Rotigotina; Rotigotine; Rotigotine (Reference product PR 2.1.1); Rotigotine (Test product PR 2.3.1); Rotigotine Nasal Spray; Rotigotine TTS (Test); Rotigotine hydrochloride; Rotigotine nasal spray; Rotigotine transdermal patch; Rotigotine transdermal patch 2mg/24h(10cm2); Rotigotine transdermal patch 4mg/24h (20cm2); Rotigotine transdermal patch 6mg/24h (30cm2); Rotigotine transdermal patch 8mg/24h (40cm2); Rotigotine, extended-release microspheres; Rozerem; Rytary 145 mg; Rytary 195 mg; S 90049; S 90049 - F36; S 90049 - F38; S.c. apomorphine; S90049; SA; SAFINAMIDE; SAFINAMIDE METANSOLFONATO; SAFINAMIDE METHANESULFONATE; SAGE-217; SAGE-718; SAM; SAM-e; SAR402671, GZ402671 or GZ/SAR402671; SARIZOTAN; SCH 420814; SCH 420814 10 mg; SCH 420814 100 mg; SCH 900800; SCH420814; SELEGILINE; SEP-363856; SER-214; SIFROL; SINEMET; SINEMET 10-100; SINEMET 100 mg + 25 mg compresse; SINEMET 125; SINEMET 25-100; SINEMET 25/100; SINEMET CR; SINEMET Plus; SINEMET*50CPR 100MG+25MG; SINEMET® Plus 25 mg/100 mg Tablets; SINEMET®-Plus Tablets; SIRIO*30CPR EFF 25MG+100MG; SK&F101468; SKF-101468A; SLV308; SLV308 (mono) hydro; SLV308 (mono) hydrochlo; SLV308 (mono) hydrochlori; SLV308 (mono) hydrochloride; SLV308 (mono)hydrochloride; SLV308 hydrochloride; SLV308(mono)hydrochloride; SMILAGENIN; SND 919 CL2 Y; SND 919 CL2Y; SNN0031; SOLIGEN; SPECT; SPM 926; SPM 962; SPM962; SQJZ herbal mixtures; SR57667B; STALEVO*100CPR 100/25/200MG; STALEVO*100CPR 50/12,5/200MG; SYN115; SYN115 Tablets, 60 mg; SYN120; Safety observation; Safinamida; Safinamide; Safinamide (as add-on therapy); Safinamide + Levodopa; Safinamide Methanesulfonate; Safinamide Methanesulfonate 100mg; Safinamide Methanesulfonate 150mg; Safinamide metansolfonato (12 weeks); Safinamide methansulfonate; Safinamide, MAO-B inhibitor; Safinimide 50-100 mg/day; Sage; Sage leaf; Saline; Saline Intranasal Delivery; Saracatinib; Sarcosine; Sarcosine Capsule; Sargramostim; Sarizotan; Sarizotan HC1; Sarizotan HCl; Sarizotan Hydrochloride; Sarizotan hydrochloride; Selegiline; Selegiline HCl 5 PCH; Semaglutide; Semi continuous intra-oral administration of LD/CD; Serine; Seroquel; Sertraline; Sevoflurane; Sifol; Sifrol; Sifrol 0,088; Sifrol 0,18; Sifrol 0,35; Sifrol 0,7; Sifrol, 0,35 mg Tablette; Sifrol, 0,70 mg Tablette; Sifrol, Mirapexin; Sifrol®; Sildenafil; Silicon; Silodosin; Simvastatin; Simvastatine; Sinemet; Sinemet (carbidopa/levodopa); Sinemet (comparator); Sinemet (levodopa/carbidopa); Sinemet 125 mg; Sinemet 200mg/50mg; Sinemet 25/100; Sinemet CR; Sinemet CR 25Mg-100Mg Extended-Release Tablet; Sinemet IR; Sinemet Plus; Sinemet plus; Sinemet plus (levodopa/carbidopa); Sinemet-Plus Tablets; Sinemet®; Sinemet® 100/25; Sinemet® 100/25 mg; Sinemet® CR; Sinemet® CR 100/25; Sinemet® controlled release (Carbidopa/levodopa); Sinemet®25-100; Sirolimus; Sitagliptin; Smilagenin; Sodium Oxybate; Sodium chloride; Sodium oxybate; Solifenacin; Solifenacin Succinate (VESIcare); Solifenacin succinate (VESIcare); Solu-Cortef; Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial'; Solu-cortef; Sorbitol; Soy protein; Spheramine (BAY86-5280); Spiropent; Stalevo; Stalevo (levodopa/ carbidopa/ entacapone); Stalevo (levodopa/carbidopa/entacapona); Stalevo (levodopa/carbidopa/entacapone); Stalevo 100; Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten; Stalevo 100 mg/25 mg / 200 mg; Stalevo 100/25/200 mg; Stalevo 150; Stalevo 150/37.5/200 mg; Stalevo®; Standard LD/CD; Standard of Care; Stilnoct; Strattera; Study Drug; Subcutaneous apomorphine; Subcutaneous hydrocortisone 10mg; Subjects will undergo the 123-I IBVM imaging visit; Sugar Pill; Sugar pill; Sulfate; Sumanirole; Supplementation; Supressi. T-Diet plus Range; Suvorexant; Synthetic Oxytocin; Syntocinon; Syntocinon 40 IU/ml nasal spray; TACROLIMUS TABLETS; TAK-071; TAVAPADON; TCE; TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt); TD-9855; TECHNETIUM (99MTC) EXAMETAZIME; THN02; THN102 Dosage A; THN102 Dosage B; THN102 Dosage C; TO; TOLCAPONE; TOPIRAMATE; TOZ; TOZADENANT; TRIGEL; TULOBUTEROL HYDROCHLORIDE; TVP-1012; TVP-1012 (1 mg/day) with levodopa; TVP-1012 0.5mg; TVP-1012 1mg; Tacrolimus; Tadalafil; Talampanel; Targinact 10 mg/5 mg prolonged-release tablets; Targinact 20 mg/10 mg prolonged-release tablets; Targinact 5 mg/2.5 mg prolonged-release tablets; Tasmar; Tavapadon; Tavapadon 0.25mg; Tavapadon 1mg; Tavapadon 5mg; Terazosin; Terazosin 5 MG; Tesofensine; Tigan; Tigan®; Tocovid Suprabio; Tolcapon; Tolcapone; Tolubuterol Hydrochloride; Topiramate; Topiramate (drug); Tozadenant; Tozadenant (SYN115) 120 mg BID; Tozadenant (SYN115) 180 mg BID; Tozadenant (SYN115) 240 mg BID; Tozadenant (SYN115) 60 mg BID; Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant); Transdermal flumazenil (Added 4/2020); Transdermal nicotine; Trihexyphenidyl; Trimethobenzamide; Trimethobenzamide Hydrochloride; Trivastal; Tropicamide; Tryptophan; Tryptophan (TRP) depletion; Tulobuterol; Tyramine; Tyrosine; UB-312; UCB0599; UCB7853; Ubiquinol; Urate; Ursodeoxycholic acid; Ursonorm; Usual dopaminergic per os treatment; V1512; V1512 and Entacapone; V81444; VARENICLINE; VARENICLINE TARTRATE; VIUSID/ALZER; VR040; VR040/Aspirair® inhaler; VY-AADC01; VY-AADC02; Valerian; Varenicline; Variation of behaviors of Parkinson's disease; Vehicle; Venglustat; Venglustat malate; Venlafaxine; ViNeuro; Vitamin B12; Vitamin B12 Supplementation; Vitamin B6; Vitamin D3; Vitamin D3 - high dose; Vitamin E; Vortioxetine; WD-1603; WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS; WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS; WIN-1001X; Warfarin; Water; Whey protein; White chocolate (0% cocoa); Wuling Powder; XADAGO (safinamide); XC130-A10H; XP21279; XP21279 and carbidopa (experimental); Xadago; Xeomin; Xiaoyao Pill; Yohimbine; Yohimbine HCl; Zelapar; Zoledronic Acid 5Mg/Bag 100Ml Inj; Zoledronic acid; Zolmitriptan; Zolpidem; Zolpidem Tartrate; Zolpidem first dose; Zolpidem second dose; Zonegran; Zonisamide; Zonisamide Capsules; Zopiclone; [11C]PBR28; [11C]PXT012253; [11C]SMW139; [123I] 5-IA; [123I] IBVM and SPECT imaging; [123I] mZINT injection and serial dynamic SPECT imaging; [123I]-IBVM; [123I]B-CIT; [123I]B-CIT SPECT imaging; [123I]CLINDE; [123I]MNI-420; [123I]beta CIT; [123I]beta CIT and SPECT imaging; [123I]beta-CIT; [123I]beta-CIT and SPECT imaging; [123I]ß CIT; [123I]ß CIT and SPECT imaging; [123I]ß-CIT; [123I]ß-CIT and SPECT imaging; [14C]-BIA 9-1067; [15O]H2O; [18F] CFPyPB; [18F] LBT-999; [18F] LBT-999 PET; [18F] PBR06; [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane; [18F]-FEPPA; [18F]DPA-714 PET scan; [18F]FDOPA; [18F]FDOPA PET/CT; [18F]FE-PE2I; [18F]FPEB; [18F]MK-9470; [18F]MNI-1126; [18F]MPPF; [18F]NOS; [18F]P17-059; [18F]PI-2620; [18F]T807 ([18F]MNI-777); [21CFR640.30] Plasma from 18 - 25 year old volunteer donors; [ABBV-951]; [F-18] Fluorodopa Positron Emission Tomography; [JNJ31-31001074]; [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03987750 (ClinicalTrials.gov)	October 2019	12/6/2019	Safinamide for Levodopa-induced Dyskinesia (PD-LID)	A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations	Dyskinesia, Drug-Induced;Parkinson Disease	Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo	Zambon SpA	NULL	Withdrawn	30 Years	N/A	All	0	Phase 3	NULL
2	NCT03881371 (ClinicalTrials.gov)	August 1, 2019	18/3/2019	A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa	A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa	Parkinson Disease	Drug: Safinamide;Other: Placebo	Zambon SpA	NULL	Recruiting	18 Years	N/A	All	306	Phase 3	China
3	NCT03841604 (ClinicalTrials.gov)	April 9, 2019	30/1/2019	Effect of Safinamide on Parkinson's Disease Related Chronic Pain	A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain	Idiopathic Parkinson Disease	Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo	Zambon SpA	NULL	Recruiting	30 Years	N/A	All	177	Phase 4	Austria;France;Germany;Italy;Spain
4	NCT03968744 (ClinicalTrials.gov)	February 18, 2019	19/4/2019	Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease	A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study	Idiopathic Parkinson's Disease (at Later Stage)	Drug: Safinamide	Alain Kaelin	Clinical Trial Unit Ente Ospedaliero Cantonale	Recruiting	18 Years	N/A	All	23	Phase 4	Switzerland
5	EUCTR2017-002426-20-AT (EUCTR)	22/01/2019	03/12/2018	Effect of Safinamide on Parkinson’s Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Zambon SpA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	177	Phase 4	Spain;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2017-002426-20-ES (EUCTR)	19/10/2018	20/08/2018	Effect of Safinamide on Parkinson’s Disease Related Chronic Pain	A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study	Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE	Zambon SpA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	177	Phase 4	Spain
7	NCT03843944 (ClinicalTrials.gov)	May 1, 2018	12/2/2019	Overnight Switch From Rasagiline To Safinamide	Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study	Parkinson Disease	Drug: Safinamide	IRCCS San Raffaele	NULL	Completed	30 Years	80 Years	All	20	Phase 4	Italy
8	NCT03648671 (ClinicalTrials.gov)	March 28, 2018	26/6/2018	Pain in Parkinson's Disease With Motor Fluctuations.	Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.	Parkinson Disease	Drug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)	Universita di Verona	Azienda Ospedaliera Universitaria Integrata Verona	Unknown status	18 Years	80 Years	All	48		Italy
9	NCT03944785 (ClinicalTrials.gov)	November 30, 2017	1/5/2019	Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)	A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets	Idiopathic Parkinson Disease	Drug: XADAGO (safinamide)	US WorldMeds LLC	NULL	Completed	30 Years	80 Years	All	209		United States
10	EUCTR2014-002600-24-AT (EUCTR)	30/12/2015	25/09/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	JPRN-JapicCTI-153057	14/12/2015	02/11/2015	ME2125 Phase III (ME2125-4)	A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon	Parkinson's disease	Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.	Meiji Seika Pharma Co., Ltd.	NULL	complete	30		BOTH	200	Phase 3	Japan
12	EUCTR2014-002600-24-IT (EUCTR)	11/12/2015	16/02/2018	Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO	ZAMBON SPA	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden
13	EUCTR2014-002600-24-SE (EUCTR)	03/12/2015	30/07/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
14	JPRN-JapicCTI-153056	24/11/2015	02/11/2015	ME2125 Phase II/III (ME2125-3)	A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon	Parkinson's disease	Intervention name : ME2125 (safinamide mesilate) INN of the intervention : safinamide Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.	Meiji Seika Pharma Co., Ltd.	NULL	complete	30		BOTH	410	Phase 2;Phase 3	Japan
15	EUCTR2014-002600-24-ES (EUCTR)	19/11/2015	05/10/2015	Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2014-002600-24-GB (EUCTR)	03/11/2015	28/07/2015	Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications	A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST	Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE	Zambon S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	556	Phase 3	France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden
17	EUCTR2008-005492-94-BG (EUCTR)	25/05/2011	23/03/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
18	EUCTR2007-002964-90-BE (EUCTR)	05/05/2011	04/09/2007	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
19	EUCTR2008-005492-94-PT (EUCTR)	14/04/2011	19/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
20	EUCTR2008-005492-94-CZ (EUCTR)	14/03/2011	03/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2008-005492-94-FI (EUCTR)	04/03/2011	13/01/2011	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
22	NCT01264861 (ClinicalTrials.gov)	March 2011	20/12/2010	A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging	Open-Label Escalating Dose Study Using [123\|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients	Parkinson Disease	Drug: Safinamide	Newron	NULL	Terminated	40 Years	80 Years	All	5	Phase 2	United States
23	EUCTR2009-017174-20-AT (EUCTR)	09/02/2011	07/12/2010	A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study	Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	24		Germany;Canada;France;Austria;South Africa
24	EUCTR2008-004146-88-DE (EUCTR)	20/12/2010	15/10/2010	An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
25	EUCTR2010-020109-34-ES (EUCTR)	29/11/2010	23/09/2010	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.	Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	Spain;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2010-020109-34-IT (EUCTR)	24/11/2010	27/12/2010	A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND	A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND	Cognition in non-demented patients with idiopathic Parkinson’s disease MedDRA version: 9.1;Level: PT;Classification code 10061536	Product Name: SAFINAMIDE Product Code: NW-1015	MERCK SERONO SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	Spain;Italy
27	EUCTR2007-002964-90-CZ (EUCTR)	06/10/2010	27/08/2010	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria
28	NCT01211587 (ClinicalTrials.gov)	September 2010	28/9/2010	A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease	A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment	Parkinson's Disease With Cognitive Impairments	Drug: safinamide;Drug: placebo	Newron	NULL	Completed	45 Years	80 Years	Both	103	Phase 2	United States;Spain
29	NCT01113320 (ClinicalTrials.gov)	April 2010	8/4/2010	Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects	A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias	Parkinson's Disease	Drug: Placebo;Drug: Safinamide	Newron	NULL	Completed	30 Years	N/A	Both	26	Phase 2	Austria;Canada;France;Germany;South Africa
30	EUCTR2009-017174-20-DE (EUCTR)	15/03/2010	07/01/2010	A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study	Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	24		France;Canada;Austria;South Africa;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2009-017174-20-FR (EUCTR)	24/02/2010	18/01/2010	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.	A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.	Idiopathic Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36		Germany;France;Austria
32	EUCTR2007-002963-28-DE (EUCTR)	17/02/2010	22/12/2009	A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
33	EUCTR2008-005492-94-BE (EUCTR)	25/01/2010	12/08/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
34	EUCTR2008-005492-94-NL (EUCTR)	18/01/2010	25/09/2009		Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients -	Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1285		Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
35	EUCTR2008-005492-94-GB (EUCTR)	09/12/2009	01/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease		Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2008-005492-94-FR (EUCTR)	25/11/2009	01/10/2009		Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients -	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1285		Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
37	EUCTR2008-005492-94-ES (EUCTR)	23/11/2009	18/09/2009		Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson -	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1285		Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
38	EUCTR2008-005492-94-HU (EUCTR)	27/10/2009	22/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285		Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
39	EUCTR2008-004146-88-PL (EUCTR)	19/10/2009	31/08/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
40	EUCTR2008-005492-94-SK (EUCTR)	14/10/2009	22/10/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	1285	Phase 3	Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2008-005492-94-AT (EUCTR)	02/10/2009	03/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
42	EUCTR2008-005492-94-EE (EUCTR)	01/10/2009	15/09/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
43	NCT01028586 (ClinicalTrials.gov)	October 2009	7/12/2009	MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)	A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist	Idiopathic Parkinson's Disease	Drug: Safinamide , MAO-B inhibitor;Drug: Placebo	Newron	NULL	Terminated	30 Years	80 Years	Both	507	Phase 3	Switzerland
44	NCT01026428 (ClinicalTrials.gov)	September 2009	1/12/2009	A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics	A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease	Idiopathic Parkinson's Disease	Drug: Safinamide + Levodopa;Other: Placebo + Levodopa	Newron	NULL	Completed	30 Years	N/A	Both	24	Phase 1;Phase 2	Italy
45	EUCTR2008-004146-88-BG (EUCTR)	13/08/2009	13/07/2009	An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2008-004146-88-PT (EUCTR)	31/07/2009	14/04/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
47	EUCTR2008-001966-10-EE (EUCTR)	16/06/2009	13/05/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
48	EUCTR2008-004146-88-ES (EUCTR)	16/06/2009	16/04/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	498	Phase 3	Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
49	EUCTR2008-004146-88-CZ (EUCTR)	08/06/2009	07/04/2009	An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
50	EUCTR2008-001966-10-AT (EUCTR)	27/05/2009	08/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2008-004146-88-IT (EUCTR)	26/05/2009	27/04/2009	A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study	A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study	Idiopatic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Name: Safinamide INN or Proposed INN: Safinamide Product Name: Safinamide INN or Proposed INN: Safinamide	MERCK SERONO SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	498	Phase 3	Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
52	EUCTR2008-004146-88-SK (EUCTR)	25/05/2009	28/05/2009	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
53	EUCTR2008-001966-10-SK (EUCTR)	25/05/2009	28/05/2009	A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Other descriptive name: NW-1015 Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Estonia;Hungary;Slovakia;Austria;United Kingdom
54	EUCTR2008-004146-88-FI (EUCTR)	19/05/2009	06/04/2009	An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist	A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	498	Phase 3	United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
55	EUCTR2008-001966-10-GB (EUCTR)	12/05/2009	27/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2008-001966-10-HU (EUCTR)	04/05/2009	06/04/2009		A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	416	Phase 3	Hungary;United Kingdom;Estonia;Austria
57	EUCTR2007-002963-28-BG (EUCTR)	03/05/2009	21/05/2009	A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
58	EUCTR2008-002769-30-IT (EUCTR)	30/04/2009	22/04/2009	A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics	A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics	Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113	Product Name: Safinamide INN or Proposed INN: Safinamide INN or Proposed INN: NACOM levodopa+cardidopa	MERCK SERONO SA	NULL	Not Recruiting			Female: yes Male: yes			Italy
59	EUCTR2008-005492-94-IT (EUCTR)	30/04/2009	15/04/2009		OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND	IDIOPATHIC PARKINSON`S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: SAFINAMIDE Product Code: NW-1015 Product Name: SAFINAMIDE Product Code: NW-1015	MERCK SERONO SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700		Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
60	EUCTR2007-002963-28-PL (EUCTR)	02/04/2009	27/02/2009	A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2007-002964-90-AT (EUCTR)	02/04/2009	13/02/2008	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
62	NCT00865579 (ClinicalTrials.gov)	April 2009	10/3/2009	Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients	Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients	Parkinson's Disease	Drug: Safinamide	Newron	NULL	Terminated	30 Years	N/A	All	964	Phase 3	Romania
63	EUCTR2007-002963-28-PT (EUCTR)	26/03/2009	07/01/2009	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A-Geneva	NULL	Not Recruiting			Female: yes Male: yes	1036	Phase 3	Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
64	EUCTR2007-002964-90-FR (EUCTR)	09/03/2009	12/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1121	Phase 3	Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
65	NCT00627640 (ClinicalTrials.gov)	February 2009	13/2/2008	Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa	A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine	Idiopathic Parkinson's Disease	Drug: Safinimide 50-100 mg/day;Drug: Matching Placebo	Newron	NULL	Completed	30 Years	80 Years	Both	549	Phase 3	United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2007-002963-28-CZ (EUCTR)	19/01/2009	30/10/2007	A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
67	EUCTR2007-002963-28-IT (EUCTR)	30/06/2008	04/01/2008	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: safinamide Product Name: safinamide	MERCK SERONO INTERNATIONAL SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	666	Phase 3	Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
68	EUCTR2007-002964-90-HU (EUCTR)	03/06/2008	15/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A.-Geneva	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
69	EUCTR2007-002964-90-GB (EUCTR)	20/03/2008	14/01/2009	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease		Merck Serono S.A - Geneva	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
70	EUCTR2007-002964-90-DE (EUCTR)	28/02/2008	17/12/2008	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	484	Phase 3	France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2007-002964-90-EE (EUCTR)	13/02/2008	02/01/2008	A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	605	Phase 3	United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
72	EUCTR2007-002964-90-ES (EUCTR)	18/01/2008	30/11/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1121	Phase 3	Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
73	EUCTR2007-002963-28-ES (EUCTR)	17/01/2008	16/11/2007	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1036	Phase 3	Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
74	EUCTR2007-002963-28-FI (EUCTR)	12/12/2007	18/10/2007	A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals SpA	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany
75	EUCTR2007-002964-90-NL (EUCTR)	11/12/2007	11/12/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1121	Phase 3	Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2007-002964-90-SK (EUCTR)	06/12/2007	16/04/2008	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 3	France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
77	EUCTR2007-002963-28-SK (EUCTR)	06/12/2007	16/04/2008	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist	Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono S.A. - Geneva	NULL	Not Recruiting			Female: yes Male: yes	839	Phase 3	Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
78	EUCTR2007-002964-90-FI (EUCTR)	04/12/2007	18/10/2007	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa	Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Merck Serono International S.A.	NULL	Not Recruiting			Female: yes Male: yes	1121	Phase 3	Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
79	NCT00605683 (ClinicalTrials.gov)	November 2007	19/12/2007	MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist	A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist	Idiopathic Parkinson's Disease	Drug: Safinamide (as add-on therapy)	Newron	NULL	Completed	30 Years	80 Years	Both	679	Phase 3	United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel
80	NCT01286935 (ClinicalTrials.gov)	August 2007	23/8/2010	18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD	A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic	Parkinson's Disease	Drug: Safinamide;Drug: Placebo	Newron	NULL	Completed	30 Years	80 Years	Both	544	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2006-005861-21-IT (EUCTR)	11/06/2007	05/01/2007	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.	Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Italy
82	NCT01187966 (ClinicalTrials.gov)	January 2007	31/5/2010	Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease	A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic	Parkinson's Disease	Drug: Safinamide;Drug: Placebo	Newron	NULL	Completed	30 Years	80 Years	Both	669	Phase 3	NULL
83	EUCTR2006-005860-14-IT (EUCTR)	19/12/2006	17/03/2009	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND	PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Italy
84	EUCTR2004-000835-27-ES (EUCTR)	18/07/2005	23/05/2006	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.	Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals S.P.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	212	Phase 3	Spain;Italy
85	NCT00642889 (ClinicalTrials.gov)	June 2005	21/3/2008	Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)	A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.	Parkinson's Disease	Drug: Safinamide;Drug: Placebo	Newron	NULL	Completed	30 Years	80 Years	Both	227	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2004-000835-27-IT (EUCTR)	03/12/2004	21/07/2005	A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: Safinamide Product Code: NW-1015	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain;Italy
87	EUCTR2004-000833-12-IT (EUCTR)	02/12/2004	15/03/2005	A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist	Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors	NEWRON PHARMACEUTICALS	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Spain;Italy
88	EUCTR2004-000833-12-ES (EUCTR)	02/12/2004	23/11/2004	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.	A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.	Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide	Newron Pharmaceuticals S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Spain;Italy
89	NCT00643045 (ClinicalTrials.gov)	December 2004	21/3/2008	Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist	A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist	Idiopathic Parkinson's Disease	Drug: Safinamide;Drug: Placebo	Newron	NULL	Completed	30 Years	80 Years	Both	269	Phase 3	NULL
90	EUCTR2008-005492-94-DE (EUCTR)		11/08/2009	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients	Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide	Newron Pharmaceuticals	NULL	Not Recruiting			Female: yes Male: yes	1285		United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03987750
(ClinicalTrials.gov)

October 2019

12/6/2019

Safinamide for Levodopa-induced Dyskinesia (PD-LID)

A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations

Dyskinesia, Drug-Induced;Parkinson Disease

Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo

Zambon SpA

NULL

Withdrawn

30 Years

N/A

All

Phase 3

NULL

NCT03881371
(ClinicalTrials.gov)

August 1, 2019

18/3/2019

A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

Parkinson Disease

Drug: Safinamide;Other: Placebo

Zambon SpA

NULL

Recruiting

18 Years

N/A

All

306

Phase 3

China

NCT03841604
(ClinicalTrials.gov)

April 9, 2019

30/1/2019

Effect of Safinamide on Parkinson's Disease Related Chronic Pain

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain

Idiopathic Parkinson Disease

Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo

Zambon SpA

NULL

Recruiting

30 Years

N/A

All

177

Phase 4

Austria;France;Germany;Italy;Spain

NCT03968744
(ClinicalTrials.gov)

February 18, 2019

19/4/2019

Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study

Idiopathic Parkinson's Disease (at Later Stage)

Drug: Safinamide

Alain Kaelin

Clinical Trial Unit Ente Ospedaliero Cantonale

Recruiting

18 Years

N/A

All

Phase 4

Switzerland

EUCTR2017-002426-20-AT
(EUCTR)

22/01/2019

03/12/2018

Effect of Safinamide on Parkinson’s Disease Related Chronic Pain

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study

Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Zambon SpA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

177

Phase 4

Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002426-20-ES
(EUCTR)

19/10/2018

20/08/2018

Effect of Safinamide on Parkinson’s Disease Related Chronic Pain

Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Xadago
Product Name: Xadago
INN or Proposed INN: Safinamide methansulfonate
Other descriptive name: SAFINAMIDE METHANESULFONATE
Trade Name: Xadago
Product Name: Xadago
INN or Proposed INN: Safinamide methansulfonate
Other descriptive name: SAFINAMIDE METHANESULFONATE

Zambon SpA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

177

Phase 4

Spain

NCT03843944
(ClinicalTrials.gov)

May 1, 2018

12/2/2019

Overnight Switch From Rasagiline To Safinamide

Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study

Parkinson Disease

Drug: Safinamide

IRCCS San Raffaele

NULL

Completed

30 Years

80 Years

All

Phase 4

Italy

NCT03648671
(ClinicalTrials.gov)

March 28, 2018

26/6/2018

Pain in Parkinson's Disease With Motor Fluctuations.

Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.

Parkinson Disease

Drug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)

Universita di Verona

Azienda Ospedaliera Universitaria Integrata Verona

Unknown status

18 Years

80 Years

All

Italy

NCT03944785
(ClinicalTrials.gov)

November 30, 2017

1/5/2019

Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets

Idiopathic Parkinson Disease

Drug: XADAGO (safinamide)

US WorldMeds LLC

NULL

Completed

30 Years

80 Years

All

209

United States

EUCTR2014-002600-24-AT
(EUCTR)

30/12/2015

25/09/2015

Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications

A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST

Idiopathic Parkinson's Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE

Zambon S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-JapicCTI-153057

14/12/2015

02/11/2015

ME2125 Phase III (ME2125-4)

A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon

Parkinson's disease

Intervention name : ME2125 (safinamide mesilate)
INN of the intervention : safinamide
Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.

Meiji Seika Pharma Co., Ltd.

NULL

complete

BOTH

200

Phase 3

Japan

EUCTR2014-002600-24-IT
(EUCTR)

11/12/2015

16/02/2018

Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications

Idiopathic Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Xadago
Product Name: Safinamide
Product Code: na
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO
Trade Name: Xadago
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO

ZAMBON SPA

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden

EUCTR2014-002600-24-SE
(EUCTR)

03/12/2015

30/07/2015

Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications

Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: SAFINAMIDE
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: SAFINAMIDE
Other descriptive name: SAFINAMIDE

Zambon S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden

JPRN-JapicCTI-153056

24/11/2015

02/11/2015

ME2125 Phase II/III (ME2125-3)

A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon

Parkinson's disease

Meiji Seika Pharma Co., Ltd.

NULL

complete

BOTH

410

Phase 2;Phase 3

Japan

EUCTR2014-002600-24-ES
(EUCTR)

19/11/2015

05/10/2015

Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications

A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST

Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: safinamide
Other descriptive name: SAFINAMIDE

Zambon S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-002600-24-GB
(EUCTR)

03/11/2015

28/07/2015

Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications

Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE

Zambon S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

556

Phase 3

France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden

EUCTR2008-005492-94-BG
(EUCTR)

25/05/2011

23/03/2011

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand

EUCTR2007-002964-90-BE
(EUCTR)

05/05/2011

04/09/2007

A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of

EUCTR2008-005492-94-PT
(EUCTR)

14/04/2011

19/01/2011

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

EUCTR2008-005492-94-CZ
(EUCTR)

14/03/2011

03/01/2011

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-005492-94-FI
(EUCTR)

04/03/2011

13/01/2011

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

NCT01264861
(ClinicalTrials.gov)

March 2011

20/12/2010

A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging

Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients

Parkinson Disease

Drug: Safinamide

Newron

NULL

Terminated

40 Years

80 Years

All

Phase 2

United States

EUCTR2009-017174-20-AT
(EUCTR)

09/02/2011

07/12/2010

A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.

A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study

Idiopathic Parkinson's disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Safinamide
Product Code: NW-1015E, EMD 1195686, MSC2191632B
INN or Proposed INN: safinamide
Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Canada;France;Austria;South Africa

EUCTR2008-004146-88-DE
(EUCTR)

20/12/2010

15/10/2010

An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany

EUCTR2010-020109-34-ES
(EUCTR)

29/11/2010

23/09/2010

Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.

Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamida
Product Code: NW-1015
Other descriptive name: Safinamida

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-020109-34-IT
(EUCTR)

24/11/2010

27/12/2010

A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND

Cognition in non-demented patients with idiopathic Parkinson’s disease
MedDRA version: 9.1;Level: PT;Classification code 10061536

Product Name: SAFINAMIDE
Product Code: NW-1015

MERCK SERONO SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

Spain;Italy

EUCTR2007-002964-90-CZ
(EUCTR)

06/10/2010

27/08/2010

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria

NCT01211587
(ClinicalTrials.gov)

September 2010

28/9/2010

A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease

A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment

Parkinson's Disease With Cognitive Impairments

Drug: safinamide;Drug: placebo

Newron

NULL

Completed

45 Years

80 Years

Both

103

Phase 2

United States;Spain

NCT01113320
(ClinicalTrials.gov)

April 2010

8/4/2010

Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias

Parkinson's Disease

Drug: Placebo;Drug: Safinamide

Newron

NULL

Completed

30 Years

N/A

Both

Phase 2

Austria;Canada;France;Germany;South Africa

EUCTR2009-017174-20-DE
(EUCTR)

15/03/2010

07/01/2010

A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

France;Canada;Austria;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-017174-20-FR
(EUCTR)

24/02/2010

18/01/2010

Idiopathic Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany;France;Austria

EUCTR2007-002963-28-DE
(EUCTR)

17/02/2010

22/12/2009

A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist

Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany

EUCTR2008-005492-94-BE
(EUCTR)

25/01/2010

12/08/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1285

Phase 3

Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands

EUCTR2008-005492-94-NL
(EUCTR)

18/01/2010

25/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients -

Idiopathic Parkinson's Disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1285

Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain

EUCTR2008-005492-94-GB
(EUCTR)

09/12/2009

01/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1285

Phase 3

Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-005492-94-FR
(EUCTR)

25/11/2009

01/10/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients -

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1285

Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain

EUCTR2008-005492-94-ES
(EUCTR)

23/11/2009

18/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson -

Idiopathic Parkinson's DiseaseEnfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1285

Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain

EUCTR2008-005492-94-HU
(EUCTR)

27/10/2009

22/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1285

Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands

EUCTR2008-004146-88-PL
(EUCTR)

19/10/2009

31/08/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy

EUCTR2008-005492-94-SK
(EUCTR)

14/10/2009

22/10/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1285

Phase 3

Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-005492-94-AT
(EUCTR)

02/10/2009

03/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

EUCTR2008-005492-94-EE
(EUCTR)

01/10/2009

15/09/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

NCT01028586
(ClinicalTrials.gov)

October 2009

7/12/2009

MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)

A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Idiopathic Parkinson's Disease

Drug: Safinamide , MAO-B inhibitor;Drug: Placebo

Newron

NULL

Terminated

30 Years

80 Years

Both

507

Phase 3

Switzerland

NCT01026428
(ClinicalTrials.gov)

September 2009

1/12/2009

A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics

A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease

Idiopathic Parkinson's Disease

Drug: Safinamide + Levodopa;Other: Placebo + Levodopa

Newron

NULL

Completed

30 Years

N/A

Both

Phase 1;Phase 2

Italy

EUCTR2008-004146-88-BG
(EUCTR)

13/08/2009

13/07/2009

An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist

Idiopathic Parkinson's Disease
MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015

Newron Pharmaceuticals

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

Phase 3

United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-004146-88-PT
(EUCTR)

31/07/2009

14/04/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy

EUCTR2008-001966-10-EE
(EUCTR)

16/06/2009

13/05/2009

A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

416

Phase 3

Hungary;United Kingdom;Estonia;Austria

EUCTR2008-004146-88-ES
(EUCTR)

16/06/2009

16/04/2009

A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918

Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

Phase 3

Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland

EUCTR2008-004146-88-CZ
(EUCTR)

08/06/2009

07/04/2009

An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist

Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany

EUCTR2008-001966-10-AT
(EUCTR)

27/05/2009

08/04/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

416

Phase 3

Hungary;United Kingdom;Estonia;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-004146-88-IT
(EUCTR)

26/05/2009

27/04/2009

Idiopatic Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's

Product Name: Safinamide
INN or Proposed INN: Safinamide
Product Name: Safinamide
INN or Proposed INN: Safinamide

MERCK SERONO SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

Phase 3

Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland

EUCTR2008-004146-88-SK
(EUCTR)

25/05/2009

28/05/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy

EUCTR2008-001966-10-SK
(EUCTR)

25/05/2009

28/05/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Other descriptive name: NW-1015
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

416

Phase 3

Estonia;Hungary;Slovakia;Austria;United Kingdom

EUCTR2008-004146-88-FI
(EUCTR)

19/05/2009

06/04/2009

An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist

Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

498

Phase 3

United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany

EUCTR2008-001966-10-GB
(EUCTR)

12/05/2009

27/04/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

416

Phase 3

Hungary;United Kingdom;Estonia;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-001966-10-HU
(EUCTR)

04/05/2009

06/04/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

416

Phase 3

Hungary;United Kingdom;Estonia;Austria

EUCTR2007-002963-28-BG
(EUCTR)

03/05/2009

21/05/2009

A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist.

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany

EUCTR2008-002769-30-IT
(EUCTR)

30/04/2009

22/04/2009

A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics

Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113

Product Name: Safinamide
INN or Proposed INN: Safinamide
INN or Proposed INN: NACOM levodopa+cardidopa

MERCK SERONO SA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

EUCTR2008-005492-94-IT
(EUCTR)

30/04/2009

15/04/2009

OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND

IDIOPATHIC PARKINSON`S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: SAFINAMIDE
Product Code: NW-1015
Product Name: SAFINAMIDE
Product Code: NW-1015

MERCK SERONO SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain

EUCTR2007-002963-28-PL
(EUCTR)

02/04/2009

27/02/2009

A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.

Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-002964-90-AT
(EUCTR)

02/04/2009

13/02/2008

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of

NCT00865579
(ClinicalTrials.gov)

April 2009

10/3/2009

Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

Parkinson's Disease

Drug: Safinamide

Newron

NULL

Terminated

30 Years

N/A

All

964

Phase 3

Romania

EUCTR2007-002963-28-PT
(EUCTR)

26/03/2009

07/01/2009

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A-Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1036

Phase 3

Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy

EUCTR2007-002964-90-FR
(EUCTR)

09/03/2009

12/11/2007

Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A. - Geneva

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1121

Phase 3

Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria

NCT00627640
(ClinicalTrials.gov)

February 2009

13/2/2008

Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine

Idiopathic Parkinson's Disease

Drug: Safinimide 50-100 mg/day;Drug: Matching Placebo

Newron

NULL

Completed

30 Years

80 Years

Both

549

Phase 3

United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-002963-28-CZ
(EUCTR)

19/01/2009

30/10/2007

A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.

Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany

EUCTR2007-002963-28-IT
(EUCTR)

30/06/2008

04/01/2008

Idiopathic Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536

Product Name: safinamide
Product Name: safinamide

MERCK SERONO INTERNATIONAL SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

666

Phase 3

Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland

EUCTR2007-002964-90-HU
(EUCTR)

03/06/2008

15/11/2007

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A.-Geneva

NULL

Not Recruiting

Female: yes
Male: yes

1121

Phase 3

France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom

EUCTR2007-002964-90-GB
(EUCTR)

20/03/2008

14/01/2009

Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Merck Serono S.A - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom

EUCTR2007-002964-90-DE
(EUCTR)

28/02/2008

17/12/2008

Idiopathic Parkinson's Disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

484

Phase 3

France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-002964-90-EE
(EUCTR)

13/02/2008

02/01/2008

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

EUCTR2007-002964-90-ES
(EUCTR)

18/01/2008

30/11/2007

A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa

Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1121

Phase 3

Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria

EUCTR2007-002963-28-ES
(EUCTR)

17/01/2008

16/11/2007

A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist

Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1036

Phase 3

Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland

EUCTR2007-002963-28-FI
(EUCTR)

12/12/2007

18/10/2007

A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.

Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals SpA

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany

EUCTR2007-002964-90-NL
(EUCTR)

11/12/2007

Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1121

Phase 3

Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-002964-90-SK
(EUCTR)

06/12/2007

16/04/2008

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom

EUCTR2007-002963-28-SK
(EUCTR)

06/12/2007

16/04/2008

Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono S.A. - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

839

Phase 3

Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy

EUCTR2007-002964-90-FI
(EUCTR)

04/12/2007

18/10/2007

Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

1121

Phase 3

Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria

NCT00605683
(ClinicalTrials.gov)

November 2007

19/12/2007

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Idiopathic Parkinson's Disease

Drug: Safinamide (as add-on therapy)

Newron

NULL

Completed

30 Years

80 Years

Both

679

Phase 3

United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel

NCT01286935
(ClinicalTrials.gov)

August 2007

23/8/2010

18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic

Parkinson's Disease

Drug: Safinamide;Drug: Placebo

Newron

NULL

Completed

30 Years

80 Years

Both

544

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2006-005861-21-IT
(EUCTR)

11/06/2007

05/01/2007

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.

Patients with idiopathic Parkinson's disease with motor fluctuations
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors

NEWRON PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Italy

NCT01187966
(ClinicalTrials.gov)

January 2007

31/5/2010

Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic

Parkinson's Disease

Drug: Safinamide;Drug: Placebo

Newron

NULL

Completed

30 Years

80 Years

Both

669

Phase 3

NULL

EUCTR2006-005860-14-IT
(EUCTR)

19/12/2006

17/03/2009

A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND

PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015

NEWRON PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Italy

EUCTR2004-000835-27-ES
(EUCTR)

18/07/2005

23/05/2006

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.

Early idiopathic Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10013113

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide

Newron Pharmaceuticals S.P.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

212

Phase 3

Spain;Italy

NCT00642889
(ClinicalTrials.gov)

June 2005

21/3/2008

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.

Parkinson's Disease

Drug: Safinamide;Drug: Placebo

Newron

NULL

Completed

30 Years

80 Years

Both

227

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2004-000835-27-IT
(EUCTR)

03/12/2004

21/07/2005

A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist

Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536

Product Name: Safinamide
Product Code: NW-1015

NEWRON PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Italy

EUCTR2004-000833-12-IT
(EUCTR)

02/12/2004

15/03/2005

A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist

Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors

NEWRON PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Italy

EUCTR2004-000833-12-ES
(EUCTR)

02/12/2004

23/11/2004

A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.

Early idiopathic Parkinson’s disease
MedDRA version: 7.0;Level: LLT;Classification code 10013113

Newron Pharmaceuticals S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 3

Spain;Italy

NCT00643045
(ClinicalTrials.gov)

December 2004

21/3/2008

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Idiopathic Parkinson's Disease

Drug: Safinamide;Drug: Placebo

Newron

NULL

Completed

30 Years

80 Years

Both

269

Phase 3

NULL

EUCTR2008-005492-94-DE
(EUCTR)

11/08/2009

Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide

Newron Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

1285

United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand