Pramipexole

Generic Name: Pramipexole

Brand Names: Mirapex, Mirapexin, Sifrol, Pramipexole Teva, Oprymea

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₇N_₃S

CAS Number: 104632-26-0

Unique Ingredient Identifier: 83619PEU5T

Background: Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) . It was first approved by the FDA in 1997 . Parkinson's Disease is one of the most common neurodegenerative disorders and...

Indication: This drug is indicated for the symptomatic treatment of Parkinson’s disease . This drug can be administered as monotherapy or in conjunction with levodopa. It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) .

Associated Conditions: Moderate restless legs syndrome (RLS), Parkinson's Disease (PD), Severe restless legs syndrome (RLS)

Associated Therapies: -

Clinical Trials

Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

Phase 3

Completed

Conditions: Parkinson Disease

Interventions: Drug: Placebo
Drug: Pramipexole

First Posted Date: 2008-01-28

Last Posted Date: 2014-06-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 511

Registration Number: NCT00601523

Locations: 🇺🇸
248.633.01016 Boehringer Ingelheim Investigational Site, La Jolla, California, United States
🇺🇸
248.633.01013 Boehringer Ingelheim Investigational Site, Oxnard, California, United States
🇦🇹
248.633.43004 Boehringer Ingelheim Investigational Site, Wien, Austria

and more 116 locations

Cognitive Enhancement in Bipolar Disorder

Phase 4

Completed

Conditions: Bipolar Disorder

Interventions: Drug: pramipexole

First Posted Date: 2008-01-18

Last Posted Date: 2015-06-12

Lead Sponsor: Northwell Health

Target Recruit Count: 50

Registration Number: NCT00597896

Locations: 🇺🇸
North Shore - Long Island Jewish Health System, Glen Oaks, New York, United States

Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

Phase 3

Completed

Conditions: Parkinson Disease

Interventions: Drug: Placebo
Drug: Pramipexole

First Posted Date: 2007-12-20

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 391

Registration Number: NCT00577460

Locations: 🇮🇳
248.634.91001 Boehringer Ingelheim Investigational Site, Delhi, India
🇭🇺
248.634.36005 Boehringer Ingelheim Investigational Site, Györ, Hungary
🇭🇺
248.634.36003 Boehringer Ingelheim Investigational Site, Kecskemét, Hungary

and more 67 locations

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

Phase 4

Completed

Conditions: Restless Legs Syndrome

Interventions: Drug: Placebo
Drug: Pramipexole

First Posted Date: 2007-05-11

Last Posted Date: 2014-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 331

Registration Number: NCT00472199

Locations: 🇬🇧
248.629.44003 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom
🇪🇸
248.629.3402 Boehringer Ingelheim Investigational Site, Barcelona, Spain
🇬🇧
248.629.44004 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom

and more 39 locations

A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients

Phase 4

Completed

Conditions: Parkinson Disease

Interventions: Drug: Placebo
Drug: Pramipexole

First Posted Date: 2006-11-22

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 312

Registration Number: NCT00402233

Locations: 🇺🇸
248.622.5 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
🇺🇸
248.622.40 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States
🇺🇸
248.622.76 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States

and more 36 locations

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

Phase 4

Completed

Conditions: Restless Legs Syndrome

First Posted Date: 2006-09-12

Last Posted Date: 2013-10-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 404

Registration Number: NCT00375284

Locations: 🇺🇸
248.616.035 Boehringer Ingelheim Investigational Site, Mesa, Arizona, United States
🇺🇸
248.616.049 Boehringer Ingelheim Investigational Site, Augusta, Georgia, United States
🇺🇸
248.616.066 Boehringer Ingelheim Investigational Site, Savannah, Georgia, United States

and more 49 locations

Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

Phase 4

Completed

Conditions: Restless Legs Syndrome
Depression

First Posted Date: 2006-07-25

Last Posted Date: 2012-05-21

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 404

Registration Number: NCT00356096

Locations: 🇫🇮
248.604.35801 Boehringer Ingelheim Investigational Site, Espoo, Finland
🇰🇷
248.604.82003 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of
🇮🇹
248.604.3909 IRCCS Fondazione "Salvatore Maugeri", Telese Terme (be), Italy

and more 51 locations

A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

Phase 4

Completed

Conditions: Restless Legs Syndrome

First Posted Date: 2006-07-07

Last Posted Date: 2012-05-21

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 369

Registration Number: NCT00349531

Locations: 🇬🇧
248.615.44009 Boehringer Ingelheim Investigational Site, Reading, United Kingdom
🇪🇸
248.615.3404 Hospital General Universitario Gregorio Marañón, Madrid, Spain
🇪🇸
248.615.3408 Hospital Nuestra Señora de Sonsoles, Avila, Spain

and more 46 locations

Profile of Depressive Symptoms in Parkinsons Disease

Completed

Conditions: Depression
Parkinson Disease

First Posted Date: 2006-07-06

Last Posted Date: 2023-12-14

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1018

Registration Number: NCT00349310

Locations: 🇫🇷
Hopital Purpan, Toulouse cedex, France
🇬🇧
Boehringer Ingelheim Investigational Site, Newark, United Kingdom
🇩🇪
Parkinson Klinik Wolfach, Wolfach, Germany

and more 15 locations

SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole

Phase 4

Completed

Conditions: Restless Legs Syndrome

First Posted Date: 2006-06-27

Last Posted Date: 2011-05-13

Lead Sponsor: Augusta University

Target Recruit Count: 20

Registration Number: NCT00344994

Locations: 🇺🇸
Medical College of Georgia, Augusta, Georgia, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy