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 causes a high level of disability in patients , leading to increased difficulty in performing activities of daily living due to symptoms that progress over time . The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 . This increase may be attributed to an aging population along with other contributing factors .

In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) . RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs .

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)

Clinical Trials

Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease

Phase 1

Completed

Conditions: Parkinson's Disease

First Posted Date: 2008-04-25

Last Posted Date: 2008-04-25

Lead Sponsor: Oregon Health and Science University

Target Recruit Count: 13

Registration Number: NCT00666653

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

Phase 3

Completed

Conditions: Restless Legs Syndrome

Interventions: Drug: Pramipexole
Drug: Placebo

First Posted Date: 2008-04-08

Last Posted Date: 2014-06-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 306

Registration Number: NCT00654498

Locations: 🇨🇳
248.630.06 Boehringer Ingelheim Investigational Site, Beijing, China
🇨🇳
248.630.07 Boehringer Ingelheim Investigational Site, Beijing, China
🇨🇳
248.630.01 Boehringer Ingelheim Investigational Site, Shanghai, China

and more 13 locations

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Completed

Conditions: Parkinson Disease

First Posted Date: 2008-04-02

Last Posted Date: 2014-05-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 286

Registration Number: NCT00651183

Locations: 🇦🇹
Boehringer Ingelheim Investigational Site, Wörgl, Austria

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

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

Phase 2

Completed

Conditions: Parkinson Disease

Interventions: Drug: Pramipexole Extended Release
Drug: Pramipexole Immediate Release

First Posted Date: 2007-11-19

Last Posted Date: 2014-07-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 112

Registration Number: NCT00560508

Locations: 🇯🇵
248.610.020 Boehringer Ingelheim Investigational Site, Akita, Akita, Japan
🇯🇵
248.610.019 Boehringer Ingelheim Investigational Site, Akashi, Hyogo, Japan
🇯🇵
248.610.014 Boehringer Ingelheim Investigational Site, Fuchu, Tokyo, Japan

and more 16 locations

Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

Phase 2

Completed

Conditions: Tourette Syndrome

Interventions: Drug: Placebo
Drug: pramipexole immediate release (IR)

First Posted Date: 2007-11-15

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 63

Registration Number: NCT00558467

Locations: 🇺🇸
248.644.0012 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
🇺🇸
248.644.0026 Boehringer Ingelheim Investigational Site, Bradenton, Florida, United States
🇺🇸
248.644.0005 Boehringer Ingelheim Investigational Site, Cambridge, Massachusetts, United States

and more 13 locations

Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

Phase 3

Completed

Conditions: Parkinson Disease

Interventions: Drug: Pramipexole Extended Release
Drug: Pramipexole Immediate Release

First Posted Date: 2007-11-14

Last Posted Date: 2014-05-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 156

Registration Number: NCT00558025

Locations: 🇫🇷
248.636.3307C Boehringer Ingelheim Investigational Site, Bron cedex, France
🇳🇱
248.636.31005 Boehringer Ingelheim Investigational Site, 's-hertogenbosch, Netherlands
🇫🇷
248.636.3303B Boehringer Ingelheim Investigational Site, Aix en Provence, France

and more 33 locations

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

Phase 3

Completed

Conditions: Early Parkinson Disease (Early PD)

Interventions: Drug: Pramipexol Immediate Release
Drug: Pramipexol Extended Release
Drug: Placebo

First Posted Date: 2007-05-28

Last Posted Date: 2014-07-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 539

Registration Number: NCT00479401

Locations: 🇭🇺
248.524.36008 Boehringer Ingelheim Investigational Site, Miskolc, Hungary
🇮🇳
248.524.91010 Boehringer Ingelheim Investigational Site, Hyderabad, India
🇮🇳
248.524.91001 Boehringer Ingelheim Investigational Site, Karnataka, India

and more 92 locations

Drug Development Updates

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

Home Terms & Conditions Privacy Policy