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	NCT03820037 (ClinicalTrials.gov)	March 2019	25/1/2019	Relative Bioavailability and Bioequivalence of Opicapone	A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects	Parkinson Disease	Drug: Ongentys;Drug: BIA 9-1067 (test)	Bial - Portela C S.A.	NULL	Not yet recruiting	18 Years	55 Years	All	45	Phase 1	United Kingdom
2	NCT03119194 (ClinicalTrials.gov)	January 27, 2017	13/4/2017	Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067	An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects	Parkinson Disease	Drug: [14C]-BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	30 Years	65 Years	Male	7	Phase 1	United Kingdom
3	NCT02847442 (ClinicalTrials.gov)	November 23, 2016	21/7/2016	Efficacy and Safety of Opicapone in Clinical Practice	Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations	Parkinson's Disease With Wearing-off Motor Fluctuations	Drug: BIA 9-1067;Drug: levodopa /dopa decarboxylase inhibitor	Bial - Portela C S.A.	NULL	Completed	30 Years	N/A	All	518	Phase 4	Germany
4	NCT02305030 (ClinicalTrials.gov)	March 2014	28/11/2014	Effect of Opicapone at Steady State on Warfarin Pharmacokinetics	Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers	Parkinson's Disease	Drug: BIA 9-1067;Drug: Warfarin	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Both	20	Phase 1	NULL
5	NCT02305017 (ClinicalTrials.gov)	March 2014	28/11/2014	Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers	Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers	Parkinson's Disease	Drug: BIA 9-1067;Drug: Paracetamol	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	28	Phase 1	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
6	NCT02305316 (ClinicalTrials.gov)	February 2014	28/11/2014	Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone	Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers	Parkinson Disease	Drug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronized	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	28	Phase 1	NULL
7	NCT01851850 (ClinicalTrials.gov)	May 2013	1/5/2013	Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial	Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial	Parkinson Disease	Drug: Opicapone	Rabin Medical Center	NULL	Completed	30 Years	80 Years	All	1	Phase 3	Israel
8	NCT02170376 (ClinicalTrials.gov)	September 2011	19/6/2014	The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics	The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa /carbidopa	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	80	Phase 1	France
9	EUCTR2010-021860-13-BG (EUCTR)	04/08/2011	02/06/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
10	EUCTR2010-021860-13-IT (EUCTR)	25/07/2011	29/03/2012	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: ComtanÂ® INN or Proposed INN: NA	BIAL - PORTELA & CÂª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina
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	EUCTR2010-021860-13-CZ (EUCTR)	24/06/2011	09/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
12	NCT01520987 (ClinicalTrials.gov)	May 2011	26/1/2012	Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects	Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Placebo	Bial - Portela C S.A.	NULL	Completed	18 Years	65 Years	All	105	Phase 1	United States
13	EUCTR2010-022366-27-CZ (EUCTR)	21/04/2011	23/11/2010	BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 13.1;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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405		Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
14	EUCTR2010-022366-27-BE (EUCTR)	18/04/2011	01/02/2011	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Czech Republic;Estonia;Belgium;United Kingdom
15	EUCTR2010-022366-27-GB (EUCTR)	23/03/2011	30/11/2010	BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 13.1;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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405	Phase 3	Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
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	EUCTR2010-021860-13-DE (EUCTR)	09/03/2011	18/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. 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]	Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
17	NCT01568073 (ClinicalTrials.gov)	March 2011	29/3/2012	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study	Parkinson's Disease	Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide	Bial - Portela C S.A.	NULL	Completed	30 Years	83 Years	All	600	Phase 3	Portugal;Austria
18	NCT02169427 (ClinicalTrials.gov)	March 2011	24/1/2012	An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites	An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral Administration	Parkinson's Disease (PD)	Drug: OPC	Bial - Portela C S.A.	NULL	Completed	18 Years	55 Years	Male	6	Phase 1	Netherlands
19	NCT01227655 (ClinicalTrials.gov)	March 2011	22/10/2010	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.	Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.	Parkinson's Disease	Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide	Bial - Portela C S.A.	NULL	Completed	30 Years	83 Years	All	427	Phase 3	Portugal
20	EUCTR2010-021860-13-SK (EUCTR)	17/02/2011	09/12/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
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	EUCTR2010-021860-13-AT (EUCTR)	27/01/2011	11/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina
22	EUCTR2010-021860-13-RO (EUCTR)	27/01/2011	25/07/2011	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550		Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Montenegro;Italy;Latvia;Austria;Lithuania;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Romania;Spain;Bosnia and Herzegovina;Croatia;Poland
23	EUCTR2010-021860-13-ES (EUCTR)	24/01/2011	27/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
24	EUCTR2010-021860-13-PT (EUCTR)	22/12/2010	08/11/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
25	EUCTR2010-021860-13-LV (EUCTR)	22/12/2010	14/10/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;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	EUCTR2010-022366-27-EE (EUCTR)	10/12/2010	03/11/2010	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II	Idiopathic Parkinson's Disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide	BIAL Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	405		Czech Republic;Estonia;Belgium;United Kingdom
27	EUCTR2010-021860-13-LT (EUCTR)	30/11/2010	28/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	MedDRA version: 16.1;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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina
28	EUCTR2010-021860-13-HU (EUCTR)	11/11/2010	27/09/2010	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I	Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease	Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067	BIAL - Portela & Ca, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550		Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
29	NCT01532115 (ClinicalTrials.gov)	May 2010	23/1/2012	Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women	A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women	Parkinson Disease	Drug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacin	Bial - Portela C S.A.	NULL	Completed	18 Years	55 Years	Both	64	Phase 1	France
30	NCT02101190 (ClinicalTrials.gov)	March 2010	20/1/2012	Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment	Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment	Parkinson's Disease	Drug: BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	18 Years	65 Years	All	16	Phase 1	France;Russian Federation
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	NCT02169414 (ClinicalTrials.gov)	February 2010	24/1/2012	Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics	Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa /carbidopa 100/25;Drug: Placebo;Drug: levodopa /benserazide 100/25 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	74	Phase 1	France
32	NCT01568047 (ClinicalTrials.gov)	February 2010	29/3/2012	Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients	Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon)	Parkinson's Disease	Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa /Carbidopa;Drug: Levodopa /Benzerazide	Bial - Portela C S.A.	NULL	Completed	30 Years	N/A	All	40	Phase 2	Romania;Ukraine
33	EUCTR2009-012897-12-RO (EUCTR)	08/12/2009	30/03/2015	A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor	A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor	Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852	Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE	BIAL-Portela & Ca, SA	NULL	Not Recruiting			Female: yes Male: yes	32		Romania
34	NCT01532128 (ClinicalTrials.gov)	November 2009	23/1/2012	Effect of BIA 9-1067 on Rasagiline Pharmacokinetics	Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects	Parkinson Disease	Drug: rasagiline;Drug: BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	24	Phase 1	France
35	NCT01532141 (ClinicalTrials.gov)	November 2009	23/1/2012	Effect of Rasagiline on BIA 9-1067 Pharmacokinetics	Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Rasagiline	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	25	Phase 1	France
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	NCT01519284 (ClinicalTrials.gov)	November 2009	23/1/2012	Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic	A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa /carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	82	Phase 1	Portugal
37	NCT02169440 (ClinicalTrials.gov)	June 2009	24/1/2012	Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin	Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Warfarin	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	20	Phase 1	Portugal
38	NCT01536366 (ClinicalTrials.gov)	June 2009	23/1/2012	Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide	Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers	Parkinson Disease	Drug: BIA 9-1067;Drug: Repaglinide	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	27	Phase 1	Portugal
39	NCT01515891 (ClinicalTrials.gov)	May 2009	19/1/2012	Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites	An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration	Parkinson Disease	Drug: BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	40 Years	55 Years	Male	4	Phase 1	Switzerland
40	NCT01568034 (ClinicalTrials.gov)	April 2009	29/3/2012	A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067	A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor	Parkinson's Disease	Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa /Carbidopa;Drug: Levodopa /Benzerazide	Bial - Portela C S.A.	NULL	Completed	30 Years	75 Years	All	10	Phase 2	Portugal;Romania;Ukraine
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	NCT01533116 (ClinicalTrials.gov)	March 2009	24/1/2012	Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide	Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Placebo;Drug: levodopa /carbidopa;Drug: levodopa /benserazide	Bial - Portela C S.A.	NULL	Completed	25 Years	45 Years	All	52	Phase 1	Canada
42	NCT01533077 (ClinicalTrials.gov)	March 2009	24/1/2012	Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa	Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Sinemet® 100/25 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	18	Phase 1	Canada
43	NCT02169466 (ClinicalTrials.gov)	January 2009	20/1/2012	Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide	Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Male	22	Phase 1	Portugal
44	EUCTR2008-003869-72-PT (EUCTR)	03/10/2008	25/06/2008	A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR	A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR	Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's	Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067	Bial - Portela & Cª, S.A.	NULL	Not Recruiting			Female: yes Male: yes	12		Portugal
45	NCT02169453 (ClinicalTrials.gov)	October 2008	20/1/2012	Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa	Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Male	12	Phase 1	Canada
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	NCT02092168 (ClinicalTrials.gov)	October 2008	20/1/2012	Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects	Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects	Parkinson Disease	Drug: BIA 9-1067	Bial - Portela C S.A.	NULL	Completed	18 Years	N/A	Male	24	Phase 1	France
47	NCT02169895 (ClinicalTrials.gov)	September 2008	20/1/2012	Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide	Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa®	Bial - Portela C S.A.	NULL	Completed	25 Years	45 Years	Male	16	Phase 1	Canada
48	NCT02169479 (ClinicalTrials.gov)	September 2008	20/1/2012	Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa	Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Male	16	Phase 1	Canada
49	NCT02071810 (ClinicalTrials.gov)	April 2008	19/1/2012	Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067	A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers	Parkinson's Disease (PD)	Drug: BIA 9-1067;Drug: Placebo	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Male	34	Phase 1	France
50	NCT01520727 (ClinicalTrials.gov)	October 2007	18/1/2012	A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects	A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects	Parkinson Disease	Drug: BIA 9-1067;Drug: Placebo	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	Male	64	Phase 1	France

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

NCT03820037
(ClinicalTrials.gov)

March 2019

25/1/2019

Relative Bioavailability and Bioequivalence of Opicapone

A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects

Parkinson Disease

Drug: Ongentys;Drug: BIA 9-1067 (test)

Bial - Portela C S.A.

NULL

Not yet recruiting

18 Years

55 Years

All

Phase 1

United Kingdom

NCT03119194
(ClinicalTrials.gov)

January 27, 2017

13/4/2017

Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067

An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects

Parkinson Disease

Drug: [14C]-BIA 9-1067

Bial - Portela C S.A.

NULL

Completed

30 Years

65 Years

Male

Phase 1

United Kingdom

NCT02847442
(ClinicalTrials.gov)

November 23, 2016

21/7/2016

Efficacy and Safety of Opicapone in Clinical Practice

Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations

Parkinson's Disease With Wearing-off Motor Fluctuations

Drug: BIA 9-1067;Drug: levodopa /dopa decarboxylase inhibitor

Bial - Portela C S.A.

NULL

Completed

30 Years

N/A

All

518

Phase 4

Germany

NCT02305030
(ClinicalTrials.gov)

March 2014

28/11/2014

Effect of Opicapone at Steady State on Warfarin Pharmacokinetics

Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers

Parkinson's Disease

Drug: BIA 9-1067;Drug: Warfarin

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Both

Phase 1

NULL

NCT02305017
(ClinicalTrials.gov)

March 2014

28/11/2014

Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

Parkinson's Disease

Drug: BIA 9-1067;Drug: Paracetamol

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

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

NCT02305316
(ClinicalTrials.gov)

February 2014

28/11/2014

Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone

Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers

Parkinson Disease

Drug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronized

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

NULL

NCT01851850
(ClinicalTrials.gov)

May 2013

1/5/2013

Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial

Parkinson Disease

Drug: Opicapone

Rabin Medical Center

NULL

Completed

30 Years

80 Years

All

Phase 3

Israel

NCT02170376
(ClinicalTrials.gov)

September 2011

19/6/2014

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa /carbidopa

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

France

EUCTR2010-021860-13-BG
(EUCTR)

04/08/2011

02/06/2011

EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose 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: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina

EUCTR2010-021860-13-IT
(EUCTR)

25/07/2011

29/03/2012

EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY

EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose 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: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: ComtanÂ®
INN or Proposed INN: NA

BIAL - PORTELA & CÂª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina

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

EUCTR2010-021860-13-CZ
(EUCTR)

24/06/2011

09/11/2010

Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina

NCT01520987
(ClinicalTrials.gov)

May 2011

26/1/2012

Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

Parkinson Disease

Drug: BIA 9-1067;Drug: Placebo

Bial - Portela C S.A.

NULL

Completed

18 Years

65 Years

All

105

Phase 1

United States

EUCTR2010-022366-27-CZ
(EUCTR)

21/04/2011

23/11/2010

BIPARK STUDY II

Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II

Idiopathic Parkinson's Disease
MedDRA version: 13.1;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: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide

BIAL Portela & Cª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

405

Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India

EUCTR2010-022366-27-BE
(EUCTR)

18/04/2011

01/02/2011

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

BIAL Portela & Cª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

405

Phase 3

Czech Republic;Estonia;Belgium;United Kingdom

EUCTR2010-022366-27-GB
(EUCTR)

23/03/2011

30/11/2010

BIPARK STUDY II

BIAL Portela & Cª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

405

Phase 3

Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India

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

EUCTR2010-021860-13-DE
(EUCTR)

09/03/2011

18/10/2010

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
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]

Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

NCT01568073
(ClinicalTrials.gov)

March 2011

29/3/2012

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study

Parkinson's Disease

Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide

Bial - Portela C S.A.

NULL

Completed

30 Years

83 Years

All

600

Phase 3

Portugal;Austria

NCT02169427
(ClinicalTrials.gov)

March 2011

24/1/2012

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral Administration

Parkinson's Disease (PD)

Drug: OPC

Bial - Portela C S.A.

NULL

Completed

18 Years

55 Years

Male

Phase 1

Netherlands

NCT01227655
(ClinicalTrials.gov)

March 2011

22/10/2010

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.

Parkinson's Disease

Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide

Bial - Portela C S.A.

NULL

Completed

30 Years

83 Years

All

427

Phase 3

Portugal

EUCTR2010-021860-13-SK
(EUCTR)

17/02/2011

09/12/2010

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

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

EUCTR2010-021860-13-AT
(EUCTR)

27/01/2011

11/10/2010

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

EUCTR2010-021860-13-RO
(EUCTR)

27/01/2011

25/07/2011

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
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]

BIAL - Portela & Ca, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Montenegro;Italy;Latvia;Austria;Lithuania;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Romania;Spain;Bosnia and Herzegovina;Croatia;Poland

EUCTR2010-021860-13-ES
(EUCTR)

24/01/2011

27/10/2010

EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy

EUCTR2010-021860-13-PT
(EUCTR)

22/12/2010

08/11/2010

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

EUCTR2010-021860-13-LV
(EUCTR)

22/12/2010

14/10/2010

Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;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

EUCTR2010-022366-27-EE
(EUCTR)

10/12/2010

03/11/2010

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

BIAL Portela & Cª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

405

Czech Republic;Estonia;Belgium;United Kingdom

EUCTR2010-021860-13-LT
(EUCTR)

30/11/2010

28/09/2010

MedDRA version: 16.1;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: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2010-021860-13-HU
(EUCTR)

11/11/2010

27/09/2010

BIAL - Portela & Ca, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy

NCT01532115
(ClinicalTrials.gov)

May 2010

23/1/2012

Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women

A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women

Parkinson Disease

Drug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacin

Bial - Portela C S.A.

NULL

Completed

18 Years

55 Years

Both

Phase 1

France

NCT02101190
(ClinicalTrials.gov)

March 2010

20/1/2012

Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

Parkinson's Disease

Drug: BIA 9-1067

Bial - Portela C S.A.

NULL

Completed

18 Years

65 Years

All

Phase 1

France;Russian Federation

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

NCT02169414
(ClinicalTrials.gov)

February 2010

24/1/2012

Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics

Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa /carbidopa 100/25;Drug: Placebo;Drug: levodopa /benserazide 100/25 mg

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

France

NCT01568047
(ClinicalTrials.gov)

February 2010

29/3/2012

Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

Multicentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon)

Parkinson's Disease

Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa /Carbidopa;Drug: Levodopa /Benzerazide

Bial - Portela C S.A.

NULL

Completed

30 Years

N/A

All

Phase 2

Romania;Ukraine

EUCTR2009-012897-12-RO
(EUCTR)

08/12/2009

30/03/2015

A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor

Parkinson’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852

Product Name: BIA 9-1067
Product Code: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Restex Tabletten
INN or Proposed INN: LEVODOPA
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE

BIAL-Portela & Ca, SA

NULL

Not Recruiting

Female: yes
Male: yes

Romania

NCT01532128
(ClinicalTrials.gov)

November 2009

23/1/2012

Effect of BIA 9-1067 on Rasagiline Pharmacokinetics

Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects

Parkinson Disease

Drug: rasagiline;Drug: BIA 9-1067

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

France

NCT01532141
(ClinicalTrials.gov)

November 2009

23/1/2012

Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects

Parkinson Disease

Drug: BIA 9-1067;Drug: Rasagiline

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

France

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

NCT01519284
(ClinicalTrials.gov)

November 2009

23/1/2012

Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects

Parkinson Disease

Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa /carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Portugal

NCT02169440
(ClinicalTrials.gov)

June 2009

24/1/2012

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Warfarin

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Portugal

NCT01536366
(ClinicalTrials.gov)

June 2009

23/1/2012

Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers

Parkinson Disease

Drug: BIA 9-1067;Drug: Repaglinide

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Portugal

NCT01515891
(ClinicalTrials.gov)

May 2009

19/1/2012

Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration

Parkinson Disease

Drug: BIA 9-1067

Bial - Portela C S.A.

NULL

Completed

40 Years

55 Years

Male

Phase 1

Switzerland

NCT01568034
(ClinicalTrials.gov)

April 2009

29/3/2012

A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor

Parkinson's Disease

Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa /Carbidopa;Drug: Levodopa /Benzerazide

Bial - Portela C S.A.

NULL

Completed

30 Years

75 Years

All

Phase 2

Portugal;Romania;Ukraine

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

NCT01533116
(ClinicalTrials.gov)

March 2009

24/1/2012

Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide

Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects

Parkinson Disease

Drug: BIA 9-1067;Drug: Placebo;Drug: levodopa /carbidopa;Drug: levodopa /benserazide

Bial - Portela C S.A.

NULL

Completed

25 Years

45 Years

All

Phase 1

Canada

NCT01533077
(ClinicalTrials.gov)

March 2009

24/1/2012

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa

Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy Subjects

Parkinson Disease

Drug: BIA 9-1067;Drug: Sinemet® 100/25 mg

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Canada

NCT02169466
(ClinicalTrials.gov)

January 2009

20/1/2012

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Male

Phase 1

Portugal

EUCTR2008-003869-72-PT
(EUCTR)

03/10/2008

25/06/2008

A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR

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

Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Code: BIA 9-1067

Bial - Portela & Cª, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Portugal

NCT02169453
(ClinicalTrials.gov)

October 2008

20/1/2012

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Male

Phase 1

Canada

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

NCT02092168
(ClinicalTrials.gov)

October 2008

20/1/2012

Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects

Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects

Parkinson Disease

Drug: BIA 9-1067

Bial - Portela C S.A.

NULL

Completed

18 Years

N/A

Male

Phase 1

France

NCT02169895
(ClinicalTrials.gov)

September 2008

20/1/2012

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa®

Bial - Portela C S.A.

NULL

Completed

25 Years

45 Years

Male

Phase 1

Canada

NCT02169479
(ClinicalTrials.gov)

September 2008

20/1/2012

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Male

Phase 1

Canada

NCT02071810
(ClinicalTrials.gov)

April 2008

19/1/2012

Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers

Parkinson's Disease (PD)

Drug: BIA 9-1067;Drug: Placebo

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Male

Phase 1

France

NCT01520727
(ClinicalTrials.gov)

October 2007

18/1/2012

A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects

A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects

Parkinson Disease

Drug: BIA 9-1067;Drug: Placebo

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

Male

Phase 1

France