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Clinical trials for pramipexole dihydrochloride

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
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    • 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    15 result(s) found for: pramipexole dihydrochloride. Displaying page 1 of 1.
    EudraCT Number: 2019-001023-13 Sponsor Protocol Number: Ox_Psych_PAXD Start Date*: 2019-11-11
    Sponsor Name:University of Oxford / Clinical Trials and Research Governance
    Full Title: PAX-D: Randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression
    Medical condition: Treatment resistant depression
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-001420-21 Sponsor Protocol Number: P2B001/003 Start Date*: 2018-06-18
    Sponsor Name:Pharma Two B Ltd
    Full Title: A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to...
    Medical condition: Early Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Restarted)
    Trial results: View results
    EudraCT Number: 2018-002869-18 Sponsor Protocol Number: Start Date*: 2019-09-04
    Sponsor Name:Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
    Full Title: A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression.
    Medical condition: Bipolar disorder (BD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10012386 Depression mental LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2006-000859-18 Sponsor Protocol Number: S308.3.008 Start Date*: 2006-09-11
    Sponsor Name:Solvay Pharmaceuticals
    Full Title: An open label SLV308 safety extension to study S308.3.003 in early PD patients
    Medical condition: Parkinson's Disease Early stage
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) EE (Completed) LT (Completed) PT (Completed) IT (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-000678-57 Sponsor Protocol Number: S308.3.003 Start Date*: 2007-06-18
    Sponsor Name:Solvay pharmaceuticals
    Full Title: A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Pa...
    Medical condition: Parkinson 's Disease early stage
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PT (Completed) EE (Completed) LT (Completed) DE (Completed) FR (Completed) NL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-005889-32 Sponsor Protocol Number: A0081186 Start Date*: 2009-07-17
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: RANDOMIZED, DOUBLE-BLIND, 12-MONTH STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEGS SYNDROME
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058920 Restless legs syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) FI (Completed) NL (Completed) AT (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001095-36 Sponsor Protocol Number: S308.3.004 Start Date*: 2008-03-27
    Sponsor Name:Solvay Pharmaceuticals
    Full Title: The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patient...
    Medical condition: advanced stage of idiopathic PD with dose-dependent motor fluctuations.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-000400-81 Sponsor Protocol Number: S308.2.008 Start Date*: 2009-04-03
    Sponsor Name:Solvay Pharmaceuticals BV
    Full Title: A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s D...
    Medical condition: Advanced Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-001096-10 Sponsor Protocol Number: S308.3.009 Start Date*: 2008-03-27
    Sponsor Name:Solvay Pharmaceuticals
    Full Title: An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations
    Medical condition: advanced stage of idiopathic PD with dose-dependent motor fluctuations.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004943-12 Sponsor Protocol Number: S308.3.010 Start Date*: 2008-11-24
    Sponsor Name:Solvay Pharmaceuticals B.V.
    Full Title: The Rubens Study: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration...
    Medical condition: Early Stage Parkinson’s Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023982-23 Sponsor Protocol Number: MAP-S-01 Start Date*: 2011-08-22
    Sponsor Name:The Stanley Medical Research Institute
    Full Title: A randomized trial administering Minocycline, Acetylsalicylic acid or Pramipexole vs Placebo as add-on to antipsychotics in patients with schizophrenia or schizoaffecive disorder
    Medical condition: schizophrenia or schizoaffecive disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000801-64 Sponsor Protocol Number: BTG001 Start Date*: 2013-02-09
    Sponsor Name:University Hospital of North Staffordshire [...]
    1. University Hospital of North Staffordshire
    2. Keele University
    Full Title: A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease.
    Medical condition: Idiopathic Parkinson's Disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10013113 Disease Parkinson's LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010282-23 Sponsor Protocol Number: Bruxism-01 Start Date*: 2010-10-26
    Sponsor Name:Tandvården SU/Mölndal
    Full Title: A randomized, open-label, cross-over study to explore a potential involvement of a dopamine related dysfunction as a mechanism behind bruxism
    Medical condition: Patients with severe oral bruxism according to Polysomnographic cut-off criteria for bruxism: more than 4 bruxism episodes per hour, more than 6 bruxism bursts per episode and/or 25 bruxism bursts ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10028037 Movement disorders (incl parkinsonism) HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004460-39 Sponsor Protocol Number: 248.644 Start Date*: 2008-11-11
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole IR (0.0625-0.5 mg/day) versus placebo for 6 weeks in children and adolescents (age...
    Medical condition: Tourette's Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044127 Tourette's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000342-32 Sponsor Protocol Number: 248.642 Start Date*: 2009-02-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open-label, flexible dose, follow-up study to evaluate safety and efficacy of oral pramipexole (0.0625-0.5 mg/day) for 24 weeks in children and adolescents (age 6-17 years) diagnosed with Touret...
    Medical condition: Tourette's Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044127 Tourette's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) Outside EU/EEA
    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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