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

Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole

Phase 4

Terminated

Conditions: Depression

Interventions: Drug: Pramipexole

First Posted Date: 2010-02-10

Last Posted Date: 2017-05-16

Lead Sponsor: Stanford University

Target Recruit Count: 16

Registration Number: NCT01066897

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease

Phase 4

Terminated

Conditions: Early-stage Parkinson's Disease

Interventions: Drug: Pramipexole
Drug: Rasagiline

First Posted Date: 2010-01-13

Last Posted Date: 2012-05-28

Lead Sponsor: Qualissima

Target Recruit Count: 112

Registration Number: NCT01048229

Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists

Phase 3

Completed

Conditions: Idiopathic Parkinson's Disease

Interventions: Drug: pramipexole or ropinirole
Drug: piribedil

First Posted Date: 2009-11-04

Last Posted Date: 2012-05-24

Lead Sponsor: Desitin Arzneimittel GmbH

Target Recruit Count: 80

Registration Number: NCT01007864

Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

Phase 3

Completed

Conditions: Restless Legs Syndrome

Interventions: Drug: placebo
Drug: pramipexole
Drug: pregabalin

First Posted Date: 2009-10-07

Last Posted Date: 2021-02-15

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 85

Registration Number: NCT00991276

Locations: 🇺🇸
Pfizer Investigational Site, Dallas, Texas, United States

A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

Phase 2

Terminated

Conditions: Advanced Stage Parkinson's Disease

Interventions: Drug: pardoprunox
Drug: pramipexole

First Posted Date: 2009-05-18

Last Posted Date: 2011-08-26

Lead Sponsor: Abbott Products

Target Recruit Count: 37

Registration Number: NCT00903838

Locations: 🇮🇹
Site Reference ID/Investigator# 45435, Cassino, Italy
🇮🇹
Site Reference ID/Investigator# 45436, Chieti Scalo, Italy
🇩🇪
Site Reference ID/Investigator# 45422, Tuebingen, Germany

and more 6 locations

Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

Phase 2

Completed

Conditions: Bipolar Depression

Interventions: Drug: quetiapine (Seroquel) XR
Drug: placebo
Drug: pramipexole dihydrochloride

First Posted Date: 2009-05-06

Last Posted Date: 2013-02-04

Lead Sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

Target Recruit Count: 96

Registration Number: NCT00893841

Locations: 🇺🇸
Affiliated Research Institute, San Diego, California, United States
🇨🇦
Copeman Neuroscience Centre, Vancouver, British Columbia, Canada
🇺🇸
Eastside Therapeutic Resource, Kirkland, Washington, United States

and more 6 locations

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Phase 3

Completed

Conditions: Idiopathic Restless Legs Syndrome

Interventions: Drug: pramipexol
Drug: placebo and pregabalin
Drug: Pregabalin

First Posted Date: 2008-12-10

Last Posted Date: 2021-01-26

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 731

Registration Number: NCT00806026

Locations: 🇬🇧
Pfizer Investigational Site, Reading Berks, United Kingdom

Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

Completed

Conditions: Restless Legs Syndrome

First Posted Date: 2008-07-24

Last Posted Date: 2014-06-04

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 549

Registration Number: NCT00721279

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

Pramipexole ER vs. Placebo in Fibromyalgia

Phase 2

Terminated

Conditions: Fibromyalgia

Interventions: Drug: pramipexole ER
Drug: placebo

First Posted Date: 2008-06-03

Last Posted Date: 2014-06-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 61

Registration Number: NCT00689052

Locations: 🇺🇸
248.637.01044 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
🇺🇸
248.637.01046 Boehringer Ingelheim Investigational Site, Medford, Oregon, United States
🇺🇸
248.637.01007 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

and more 39 locations

Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome

Phase 3

Terminated

Conditions: Tourette Syndrome

Interventions: Drug: pramipexole 0.125 mg BID
Drug: pramipexole 0.125 mg TID
Drug: pramipexole 0.0625 mg QD
Drug: pramipexole 0.0625 mg BID
Drug: pramipexole 0.25 mg BID

First Posted Date: 2008-05-21

Last Posted Date: 2014-05-23

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 45

Registration Number: NCT00681863

Locations: 🇺🇸
248.642.0013 Boehringer Ingelheim Investigational Site, Orangeburg, New York, United States
🇺🇸
248.642.0010 Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States
🇺🇸
248.642.0029 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

and more 11 locations

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