MedPath

Pramipexole

Generic Name
Pramipexole
Brand Names
Mirapex, Mirapexin, Sifrol, Pramipexole Teva, Oprymea
Drug Type
Small Molecule
Chemical Formula
C10H17N3S
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)

Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD

Phase 2
Terminated
Conditions
Opioid Withdrawal
Sleep Disorder
Restless Legs Syndrome
Opioid-use Disorder
Interventions
Drug: Placebo
First Posted Date
2021-02-18
Last Posted Date
2025-05-09
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
75
Registration Number
NCT04759703
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Gavin Foundation Clinical Stabilization Services, Quincy, Massachusetts, United States

Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets

Not Applicable
Terminated
Conditions
Parkinson's Disease
First Posted Date
2020-02-19
Last Posted Date
2023-03-31
Lead Sponsor
First Affiliated Hospital of Zhejiang University
Target Recruit Count
30
Registration Number
NCT04275492
Locations
🇨🇳

The First Affiliated Hospital,ZheJiang Univercity, Hanzhou, Zhejiang, China

Social Decision Making in Parkinson's Disease

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
Drug: Placebo
First Posted Date
2020-01-31
Last Posted Date
2023-10-18
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
18
Registration Number
NCT04249544
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Pramipexole and Morphine for Renal Colic

Phase 1
Completed
Conditions
Renal Colic
Interventions
Drug: Placebo oral tablet
First Posted Date
2019-11-13
Last Posted Date
2023-03-08
Lead Sponsor
East Carolina University
Target Recruit Count
19
Registration Number
NCT04160520
Locations
🇺🇸

Vidant Medical Center ED, Greenville, North Carolina, United States

Pramipexole to Target "Anhedonic Depression"

Phase 2
Completed
Conditions
Dysthymia
Anhedonia
Depression, Bipolar
Depression, Unipolar
Interventions
First Posted Date
2019-10-09
Last Posted Date
2021-09-16
Lead Sponsor
Region Skane
Target Recruit Count
13
Registration Number
NCT04121091
Locations
🇸🇪

Psychiatry Clinic, Lund, Region Skåne, Lund, Sweden

A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

Phase 2
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2019-02-19
Last Posted Date
2021-02-17
Lead Sponsor
Kissei Pharmaceutical Co., Ltd.
Target Recruit Count
74
Registration Number
NCT03845387
Locations
🇯🇵

Research Site, Multiple Locations, Japan

Non-Opioid Pramipexole and Pain

Early Phase 1
Completed
Conditions
Chronic Pain
Interventions
First Posted Date
2019-02-15
Last Posted Date
2024-10-23
Lead Sponsor
University of New Mexico
Target Recruit Count
13
Registration Number
NCT03842709
Locations
🇺🇸

University of New Mexico Hospital, Albuquerque, New Mexico, United States

Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Phase 4
Terminated
Conditions
Restless Legs Syndrome
Interventions
Other: placebo
First Posted Date
2019-01-25
Last Posted Date
2021-12-09
Lead Sponsor
Dong Jie
Target Recruit Count
21
Registration Number
NCT03817554
Locations
🇨🇳

Peking University First Hospital, Beijing, China

Pramipexole and Emotional Processing

Not Applicable
Completed
Conditions
Reward
Emotions
Motivation
Dopamine
Interventions
Drug: Placebo
First Posted Date
2018-09-24
Last Posted Date
2020-03-24
Lead Sponsor
University of Oxford
Target Recruit Count
43
Registration Number
NCT03681509
Locations
🇬🇧

Dept of Psychiatry, University of Oxford, Oxford, Oxfordshire, United Kingdom

The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2018-05-11
Last Posted Date
2021-02-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
98
Registration Number
NCT03521635
Locations
🇨🇳

The First Afiliated Hospital, Sun Yet-sen University, Guangzhou, China

🇨🇳

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

🇨🇳

Wuhan Union Hospital, Wuhan, China

and more 9 locations
© Copyright 2025. All Rights Reserved by MedPath