Drugs / Pramipexole
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Pramipexole

targets NLRP3 via inhibition

Developed for
Parkinson disease · restless legs syndrome · major depressive disorder · depressive disorder · bipolar disorder · amyotrophic lateral sclerosis · obsessive-compulsive disorder · atypical depressive disorder
+16 more · bipolar depression · binge eating disorder · chronic pain syndrome · dysthymic disorder · extrapyramidal and movement disease · fibromyalgia · post-traumatic stress disorder · substance withdrawal syndrome · Tourette syndrome · urinary system disorder · anxiety · cocaine abuse · cocaine dependence · essential tremor · schizoaffective disorder · schizophrenia
Investigated by
Boehringer Ingelheim · National Institute of Mental Health (NIMH) · Bennett, James P., Jr., M.D., Ph.D. · Chase Therapeutics Corporation · Clinical Academic Center (2CA-Braga) · GlaxoSmithKline
+41 more · Icahn School of Medicine at Mount Sinai · Lund University · Massachusetts General Hospital · Northwell Health · Pharma Two B Ltd. · Region Skane · Research Foundation for Mental Hygiene, Inc. · Stanford University · United States Department of Defense · University of Pittsburgh · All India Institute of Medical Sciences, Bhubaneswar · AstraZeneca · Augusta University · Brigham and Women's Hospital · Cardiocentro Ticino · Columbia University · Daniel Lindqvist · Dong Jie · Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. · East Carolina University · Indian Council of Medical Research · Insel Gruppe AG, University Hospital Bern · Institute for Neurodegenerative Disorders · Kissei Pharmaceutical Co., Ltd. · Mauro Manconi · Mclean Hospital · National Alliance for Research on Schizophrenia and Depression · Neuropsychiatric Research Institute, Fargo, North Dakota · New York State Psychiatric Institute · Oregon Health and Science University · Sandoz · Shanghai Mental Health Center · Stanley Medical Research Institute · The Zucker Hillside Hospital · University Hospital Muenster · University of California, San Francisco · University of Minho · University of Nebraska · University of New Mexico · University of Oxford · Vanderbilt University Medical Center

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) MIRAPEX ER 2012-08-31 fda.gov
Label expansions (2) US (FDA) MIRAPEX 2006-11-07 – 2011-05-13 fda.gov
Approved EU (EMA) Sifrol 1997-10-13 europa.eu
Approved US (FDA) MIRAPEX 1997-07-01 fda.gov

Trials 75 · started per year

today
US approved 1997
EU approved 1997
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19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03842709 May 2019 → Jan 2020 chronic pain syndrome University of New Mexico Completed No outcome recorded
Phase 0 NCT03430596 May 2018 → Oct 2021 extrapyramidal and movement disease Shanghai Mental Health Center Completed No outcome recorded
Phase 18 trials
Phase 1 NCT06457204 Jul → Aug 2024 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT04249544 Dec 2019 → Jun 2022 Parkinson disease Vanderbilt University Medical Center Completed No outcome recorded
Phase 1 NCT02262546 May → Oct 2007 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02264132 Sep → Nov 2006 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT00471588 Aug 2006 → Dec 2007 obsessive-compulsive disorder GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02261103 Apr → Jul 2006 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02261090 Jun → Sep 2004 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT00666653 Jul 2003 → May 2007 Parkinson disease Oregon Health and Science University Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04160520 Oct 2019 → Jan 2023 urinary system disorder East Carolina University Completed No outcome recorded
Phase 1/2 NCT00600873 Aug 2007 → Sep 2008 amyotrophic lateral sclerosis Bennett, James P., Jr., M.D., Ph.D. Completed No outcome recorded
Phase 1/2 NCT00140218 Aug 2005 → Jan 2007 amyotrophic lateral sclerosis Bennett, James P., Jr., M.D., Ph.D. Completed No outcome recorded
Phase 216 trials
Phase 2 NCT07022405 Jan 2026 → Aug 2030 expected major depressive disorder Stanford University Recruiting No outcome recorded
Phase 2 NCT06611592 Aug 2024 → Aug 2028 expected obsessive-compulsive disorder Clinical Academic Center (2CA-Braga) Recruiting No outcome recorded
Phase 2 NCT05401019 Jun 2022 → Dec 2026 obsessive-compulsive disorder Clinical Academic Center (2CA-Braga) Withdrawn No outcome recorded
Phase 2 NCT04121091 Oct 2019 → Mar 2021 atypical depressive disorder, bipolar depression, dysthymic disorder, major depressive disorder Region Skane Completed No outcome recorded
Phase 2 NCT03683225 Apr 2019 → Dec 2025 overdue Parkinson disease Chase Therapeutics Corporation Active not recruiting No outcome recorded
Phase 2 NCT03845387 Feb 2019 → Feb 2020 Parkinson disease Kissei Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT03642964 Sep 2018 → Dec 2025 overdue major depressive disorder Chase Therapeutics Corporation Active not recruiting No outcome recorded
Phase 2 NCT00893841 Feb 2009 → Jan 2013 bipolar depression Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. Completed No outcome recorded
Phase 2 NCT00689052 Jul → Nov 2008 fibromyalgia Boehringer Ingelheim Terminated No outcome recorded
Phase 2 NCT00558467 Jan 2008 → Jun 2009 Tourette syndrome Boehringer Ingelheim Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04759703 Jan 2022 → May 2024 opiate dependence, restless legs syndrome, sleep disorder, substance withdrawal syndrome Massachusetts General Hospital Terminated No outcome recorded
Phase 2/3 NCT01968460 Dec 2013 → May 2015 Parkinson disease Pharma Two B Ltd. Completed No outcome recorded
Phase 2/3 NCT00560508 Nov 2007 → Nov 2009 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 319 trials
Phase 3 NCT07664852 Sep 2026 → Dec 2029 expected bipolar disorder Daniel Lindqvist Not yet recruiting No outcome recorded
Phase 3 NCT05825235 Apr 2023 → Dec 2025 atypical depressive disorder, depressive disorder Region Skane Completed No outcome recorded
Phase 3 NCT03765138 Feb → Aug 2019 major depressive disorder, post-traumatic stress disorder Research Foundation for Mental Hygiene, Inc. Terminated No outcome recorded
Phase 3 NCT03329508 Jan 2018 → Aug 2021 Parkinson disease Pharma Two B Ltd. Completed No outcome recorded
Phase 3 NCT01191944 Aug 2010 → Jan 2012 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT01106053 Apr 2010 → Jul 2011 binge eating disorder Neuropsychiatric Research Institute, Fargo, North Dakota Withdrawn No outcome recorded
Phase 3 NCT00654498 Apr 2008 → Jun 2009 restless legs syndrome Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00558025 Oct 2007 → May 2008 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00479401 May 2007 → Nov 2008 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 3 NCT00466167 Apr 2007 → Nov 2008 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 422 trials
Phase 4 NCT06580041 Nov 2024 → Sep 2029 expected major depressive disorder University of California, San Francisco Enrolling by invitation No outcome recorded
Phase 4 NCT04936126 Aug 2021 → Jul 2024 All India Institute of Medical Sciences, Bhubaneswar Unknown No outcome recorded
Phase 4 NCT03817554 Jul 2019 → Aug 2020 restless legs syndrome Dong Jie Terminated No outcome recorded
Phase 4 NCT03521635 Jul 2018 → Jan 2020 Parkinson disease Boehringer Ingelheim Completed No outcome recorded
Phase 4 NCT02397837 Oct 2014 → Jul 2018 bipolar disorder Brigham and Women's Hospital Completed No outcome recorded
Phase 4 NCT02033369 Feb 2014 → Dec 2016 major depressive disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 4 NCT02025608 Dec 2013 → Dec 2016 restless legs syndrome Mauro Manconi Completed No outcome recorded
Phase 4 NCT01673724 Feb 2012 → May 2016 Parkinson disease Sandoz Completed No outcome recorded
Phase 4 NCT01066897 Feb 2010 → Feb 2013 depressive disorder Stanford University Terminated No outcome recorded
Phase 4 NCT00472199 May 2007 → Jul 2008 restless legs syndrome Boehringer Ingelheim Completed No outcome recorded
Phase not applicable1 trial
NCT03681509 Sep 2018 → Nov 2019 University of Oxford Completed No outcome recorded
Phase not stated1 trial
NCT00596115 amyotrophic lateral sclerosis Bennett, James P., Jr., M.D., Ph.D. Temporarily not available No outcome recorded
Also used as a comparator or background therapy in 29 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07240675 Comparator Nov 2025 → Sep 2026 expected Hunan Kelun Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT01651377 Comparator Oct 2011 → Dec 2012 cocaine abuse, cocaine dependence Baylor College of Medicine Completed No outcome recorded
Phase 1 NCT02260024 Comparator Oct → Dec 2005 Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT01074450 Comparator Feb → Mar 2005 Teva Pharmaceuticals USA Completed No outcome recorded
Phase 1 NCT01074463 Comparator Feb → Mar 2005 Teva Pharmaceuticals USA Completed No outcome recorded
Phase 25 trials
Phase 2 NCT06269146 Comparator May 2024 → Mar 2026 overdue anxiety, depressive disorder University of California, San Diego Recruiting No outcome recorded
Phase 2 NCT02347059 Comparator Jan 2015 → Aug 2016 Parkinson disease University of Toronto Unknown No outcome recorded
Phase 2 NCT00903838 Comparator Sep 2009 → May 2011 Parkinson disease Abbott Products Terminated No outcome recorded
Phase 2 NCT00537017 Background Nov 2007 → Nov 2009 Parkinson disease, movement disorder, neurodegenerative disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT00406029 Background Nov 2006 → Oct 2008 Parkinson disease, movement disorder, neurodegenerative disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 311 trials
Phase 3 NCT05355337 Comparator Feb 2023 → Jun 2025 atypical depressive disorder, depressive disorder Region Skane Completed No outcome recorded
Phase 3 NCT01441284 Comparator Dec 2017 → Dec 2018 essential tremor University of Pecs Withdrawn No outcome recorded
Phase 3 NCT01320982 Comparator Mar 2011 → Jun 2012 schizoaffective disorder, schizophrenia Sheba Medical Center Unknown No outcome recorded
Phase 3 NCT01007864 Comparator Jan 2010 → Dec 2011 Parkinson disease Desitin Arzneimittel GmbH Completed No outcome recorded
Phase 3 NCT00991276 Comparator Dec 2009 → Jun 2011 restless legs syndrome Viatris Inc. Completed No outcome recorded
Phase 46 trials
Phase 4 NCT05003648 Comparator Apr 2023 → Jul 2025 overdue adrenoleukodystrophy, restless legs syndrome Massachusetts General Hospital Active not recruiting No outcome recorded
Phase 4 NCT03977441 Background Jul 2019 → Dec 2020 Parkinson disease, circadian rhythm sleep disorder, depressive disorder Second Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 4 NCT02670161 Comparator May 2016 → Dec 2026 expected Parkinson disease, brain neoplasm, cognitive impairment with or without cerebellar ataxia, epilepsy +6 Endeavor Health Enrolling by invitation No outcome recorded
Phase 4 NCT01048229 Comparator Oct 2008 → Mar 2010 Parkinson disease Qualissima Terminated No outcome recorded
Phase 4 NCT00399477 Background Oct 2006 → Jul 2007 Parkinson disease Teva Neuroscience, Inc. Completed No outcome recorded
Phase not applicable2 trials
NCT01470859 Comparator Dec 2011 → Aug 2014 Parkinson disease Huashan Hospital Completed No outcome recorded
NCT00282152 Background Mar 2006 → Jan 2012 Parkinson disease Vanderbilt University Medical Center Completed No outcome recorded

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 107 sources stand behind the page.

FieldValueCited text
Known as Pramipexole “The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the...” NCT00479401
99

“The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified...” NCT00466167

“Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O...” NCT00537017

“Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the...” NCT00406029

“A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio...” NCT00275275

“Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease” NCT02231905

“Different doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients” NCT02231918

Pramipexole group: Consenting individuals meeting accession criteria will start pramipexole 2.0mg daily dose” NCT03642964

“Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years.” PMID 28078162 Dec 2016

“Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.” NCT00282152

“control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine” NCT03977441

“Parkinson's disease (pramipexole, ropinerole, rotigotine)” NCT02670161

pramipexole ER, given with aprepitant” NCT03683225

NCT00472199

NCT00297778

NCT00601523

NCT00991276

NCT04160520

NCT00152997

NCT00471588

NCT02172573

NCT03765138

NCT00597896

NCT00144209

NCT01673724

NCT03842709

NCT01007864

NCT02264132

NCT03329508

NCT02025608

NCT00560508

NCT02261103

NCT00356096

NCT00152958

NCT01441284

NCT05355337

NCT01470859

NCT00231959

NCT00344994

NCT00558467

NCT02260024

NCT02261090

NCT00893841

NCT05825235

NCT01074450

NCT03681509

NCT06457204

NCT00102856

NCT03521635

NCT06269146

NCT01968460

NCT01048229

NCT05003648

NCT03817554

NCT00577460

NCT02177357

NCT01074463

NCT00596115

NCT02033369

NCT01106053

NCT00274131

NCT00096720

NCT00349531

NCT00654498

NCT02397837

NCT05401019

NCT03845387

NCT00335166

NCT00239486

NCT07022405

NCT02233023

NCT01320982

NCT04249544

NCT00666653

NCT07240675

NCT00689052

NCT00558025

NCT00390689

NCT00240409

NCT07664852

NCT02347059

NCT00681863

NCT00086307

NCT04936126

NCT00903838

NCT00133198

NCT01191944

NCT01651377

NCT04121091

NCT00321854

NCT04759703

NCT02262546

NCT06580041

NCT06611592

NCT00402233

NCT00275457

NCT03430596

NCT01066897

NCT00025792

NCT00375284

Known as BI Sifrol “Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease” NCT02231905
2

“The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design.” NCT00274131

“Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome” NCT00152997

Known as Mirapex “The dose and route of administration of pramipexole will be identical to that previously approved for the treatment of Restless Legs Syndrome and according to manufacturer's...” NCT03842709
9

“Preliminary studies suggest that pramipexole (Mirapex), a dopaminergic-agent that is FDA-approved for Parkinson's Disease, may have antidepressant properties in unipolar and...” NCT00025792

“A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio...” NCT00275275

“A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS” NCT00375284

“This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.” NCT00231959

“fixed doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally” NCT00133198

“Pramipexole (Mirapex) tablets are taken orally, with or without food.” NCT06269146

Mirapex (pramipexole)” NCT00096720

Mirapex (pramipexole)” NCT00344994

NCT00399477

Known as Mirapexin “A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term...” NCT00472199
2

“Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks” NCT00356096

“Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os” NCT00349531

Known as PPX “The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.” NCT00689052
4

“R+ pramipexole (PPX) is a lipophilic cation that concentrates into brain and mitochondria and efficiently scavenges reactive oxygen and nitrogen species (RONS).” PMID 18270879 Feb 2008

“Subjects were randomized to receive either pramipexole (PPX) or placebo for the initial 5 weeks of the study” NCT00666653

“pharmacokinetics (PK) of pramipexole (PPX) after administration” NCT02231918

“dopamine agonist pramipexole (PPX) versus reference treatment” PMID 22101745 Nov 2011

Known as PPX ER “Pramipexole Extended Release (PPX ER)” NCT00479401
Known as PPX IR “Pramipexole Immediate Release (PPX IR)” NCT00479401
Known as pramipexol ClinicalTrials.gov intervention name — accepted as the source's own label NCT00806026
1

NCT00479401

Known as Pramipexol Extended Release “Drug: Pramipexol Extended ReleaseNCT00466167
1

“Drug: Pramipexol Extended ReleaseNCT00479401

Known as Pramipexol Immediate Release “Drug: Pramipexol Immediate ReleaseNCT00466167
1

“Drug: Pramipexol Immediate ReleaseNCT00479401

Known as Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc.” NCT01074450
1

Pramipexole Dihydrochloride 0.25 mg Tablets” NCT01074463

Known as pramipexole ER “The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified...” NCT00466167
3

“In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER.” NCT03329508

pramipexole ER, given with aprepitant” NCT03683225

“Drug: pramipexole ERNCT00689052

Known as Pramipexole Extended Release “The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the...” NCT00479401
1

“A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER)...” NCT00466167

Known as pramipexole hydrochloride “10 volunteers receive pramipexole hydrochloride sustained-release tablets 0.375mg” NCT07240675
Known as pramipexole immediate release “A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER)...” NCT00466167
1

“the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity” NCT00479401

Known as R(+)PPX “R(+) pramipexole dihydrochloride monohydrate \[R(+)PPX\], an experimental neuroprotective drug” NCT00596115
Known as R+ pramipexole R+ pramipexole (PPX) is a lipophilic cation that concentrates into brain and mitochondria and efficiently scavenges reactive oxygen and nitrogen species (RONS).” PMID 18270879 Feb 2008
2

NCT00600873

NCT00140218

Known as Ropirinole ClinicalTrials.gov intervention name — accepted as the source's own label NCT02347059
Known as Sifrol “A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term...” NCT00472199
7

“A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With...” NCT00275457

“1 tablet Sifrol® (pramipexole) manufactured in Ingelheim containing 0.088 mg pramipexole taken orally after an overnight fast of at least 10 hours.” NCT06457204

“Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks” NCT00356096

“Pramipexole (Sifrol®, Mirapexin®) 0.125-0.75 mg/Day Per os” NCT00349531

“0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n.” NCT00654498

“pramipexole (Sifrol) 0.25 mg to 0.75 mg daily” NCT00144209

“different doses of pramipexole (Sifrol)” NCT00239486

Known as SND 919 “The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease...” NCT02172573
Action Activate “The D₂/D₃ receptor agonist pramipexole has clinical efficacy as an antidepressant” PMID 21029512 Oct 2010
Route Oral “Administered Orally” NCT00133198
Target NLRP3 “pramipexole blocks the activation of NLRP3NCT03842709