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Clinical trials for Istradefylline

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    5 result(s) found for: Istradefylline. Displaying page 1 of 1.
    EudraCT Number: 2004-002844-93 Sponsor Protocol Number: 6002-INT-001 Start Date*: 2005-02-08
    Sponsor Name:Kyowa Hakko U.K. Limited
    Full Title: A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Lev...
    Medical condition: Parkinson's Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) GB (Completed) EE (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-000817-20 Sponsor Protocol Number: 6002-EU-007 Start Date*: 2004-10-22
    Sponsor Name:Kyowa Hakko U.K. Limited
    Full Title: A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entac...
    Medical condition: Parkinson's Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) AT (Completed) LT (Completed) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-003887-34 Sponsor Protocol Number: 6002-018 Start Date*: 2016-04-12
    Sponsor Name:Kyowa Kirin Pharmaceutical Development, Inc.
    Full Title: A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson’s Disease
    Medical condition: Moderate to severe Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002254-70 Sponsor Protocol Number: 6002-014 Start Date*: 2014-02-28
    Sponsor Name:Kyowa Kirin Pharmaceutical Development, Inc.
    Full Title: A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Sever...
    Medical condition: Moderate to severe Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    19.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002951-40 Sponsor Protocol Number: CVL-751-PD-003 Start Date*: 2020-07-29
    Sponsor Name:Cerevel Therapeutics, LLC
    Full Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parki...
    Medical condition: Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Ongoing) FR (Completed) HU (Completed) BG (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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