SAFINAMIDE ( DrugBank: Safinamide )
2 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
6 | パーキンソン病 | 94 |
17 | 多系統萎縮症 | 3 |
6. パーキンソン病
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
Showing 1 to 10 of 94 diseases
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 |
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1 | EUCTR2018-004892-11-IT (EUCTR) | 22/04/2021 | 07/10/2020 | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinami ... | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients - SteP-on A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinami ... | •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD•A Modified Hoehn and Yahr stage of = 4 in the off” state;•A stable (4 weeks since last modification) anti-parkinsonian therapy; •The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs frozen” or glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD•A Modifie ... | Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- ... | OSPEDALE SANTA MARIA DELLA MISERICORDIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 3 | Italy | ||
2 | NCT03987750 (ClinicalTrials.gov) | October 2019 | 12/6/2019 | Safinamide for Levodopa-induced Dyskinesia (PD-LID) | A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety ... | Dyskinesia, Drug-Induced;Parkinson Disease | Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo Drug: SafinamideMethanesulfonate 150mg;Drug: SafinamideMethanesulfonate 100mg;Drug: SafinamideMethan ... | Zambon SpA | NULL | Withdrawn | 30 Years | N/A | All | 0 | Phase 3 | NULL |
3 | NCT03881371 (ClinicalTrials.gov) | August 1, 2019 | 18/3/2019 | A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese ... | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinami ... | Parkinson Disease | Drug: Safinamide;Other: Placebo | Zambon SpA | NULL | Completed | 18 Years | N/A | All | 307 | Phase 3 | China |
4 | NCT03841604 (ClinicalTrials.gov) | April 9, 2019 | 30/1/2019 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinami ... | Idiopathic Parkinson Disease | Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo | Zambon SpA | NULL | Completed | 30 Years | N/A | All | 71 | Phase 4 | Austria;France;Germany;Italy;Spain |
5 | EUCTR2017-002426-20-FR (EUCTR) | 05/04/2019 | 26/11/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinami ... | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, exp ... | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamidemethansulfonate Other descriptiv ... | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria | ||
6 | EUCTR2017-002426-20-IT (EUCTR) | 21/02/2019 | 07/10/2020 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson's Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinami ... | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, expe ... | Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDEMETANSOLFONATO ... | ZAMBON SPA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria;Germany;Italy | ||
7 | NCT03968744 (ClinicalTrials.gov) | February 18, 2019 | 19/4/2019 | Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease | A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamideon Sleep Q ... | Idiopathic Parkinson's Disease (at Later Stage) | Drug: Safinamide | Alain Kaelin | Clinical Trial Unit Ente Ospedaliero Cantonale | Recruiting | 18 Years | N/A | All | 23 | Phase 4 | Switzerland |
8 | EUCTR2017-002426-20-AT (EUCTR) | 22/01/2019 | 03/12/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinami ... | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, exp ... | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamidemethansulfonate Other descriptiv ... | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 4 | Spain;Austria | ||
9 | EUCTR2017-002426-20-ES (EUCTR) | 19/10/2018 | 20/08/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinami ... | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, exp ... | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamidemethansulfonate Other descriptiv ... | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 177 | Phase 4 | Spain | ||
10 | NCT03843944 (ClinicalTrials.gov) | May 1, 2018 | 12/2/2019 | Overnight Switch From Rasagiline To Safinamide | Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study Overnight Switch From Rasagiline To SafinamideIn Fluctuating Patients With Parkinson's Disease: A To ... | Parkinson Disease | Drug: Safinamide | IRCCS San Raffaele | NULL | Completed | 30 Years | 80 Years | All | 20 | Phase 4 | Italy |
17. 多系統萎縮症
臨床試験数 : 118 / 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 112
Showing 1 to 3 of 3 diseases
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 |
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1 | NCT03753763 (ClinicalTrials.gov) | October 29, 2019 | 19/11/2018 | Safinamide for Multiple System Atrophy (MSA) | 12-weeks, Multicentre, Randomized, Double-blind, Placebo-controlled, Exploratory, Pilot Study to Evaluate the Safety and Efficacy of Safinamide 200 mg OD, as add-on Therapy, in Patients With Possible or Probable Parkinsonian Variant of MSA 12-weeks, Multicentre, Randomized, Double-blind, Placebo-controlled, Exploratory, Pilot Study to Eva ... | Multiple System Atrophy | Drug: Safinamide Methanesulfonate;Drug: Safinamide Methanesulfonate matching placebo | Zambon SpA | NULL | Completed | 30 Years | 80 Years | All | 49 | Phase 2 | Italy;Spain |
2 | EUCTR2018-004145-16-IT (EUCTR) | 05/09/2019 | 21/01/2021 | A study evaluating the safety and efficacy of safinamide for patients with Multiple System Atrophy | A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy. - Safinamide for Multiple System Atrophy A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to e ... | Parkinsonian variant of Multiple System Atrophy MedDRA version: 21.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Parkinsonian variant of Multiple System Atrophy MedDRA version: 21.1;Level: PT;Classification code 1 ... | Trade Name: Xadago Product Name: Xadago Product Code: [Z7219] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: Xadago Product Code: [Z7219] INN or Proposed INN: SAFINAMIDEMETANSOLFO ... | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Spain;Italy | ||
3 | EUCTR2018-004145-16-ES (EUCTR) | 24/07/2019 | 11/06/2019 | A study evaluating the safety and efficacy of safinamide for patients with Multiple System Atrophy | A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy. - Safinamide for Multiple System Atrophy A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to e ... | Parkinsonian variant of Multiple System Atrophy MedDRA version: 20.0;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] Parkinsonian variant of Multiple System Atrophy MedDRA version: 20.0;Level: PT;Classification code 1 ... | Trade Name: Xadago INN or Proposed INN: safinamide methanesulfonate Other descriptive name: SAFINAMIDE | Zambon SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | Spain |