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

a Pilot Study of Pramipexole to Treat Extrapyramidal Symptoms Induced by Antipsychotics

Early Phase 1

Completed

Conditions: Extrapyramidal Syndrome

Interventions: Drug: Trihexyphenidyl hydrochloride
Drug: Pramipexole

First Posted Date: 2018-02-13

Last Posted Date: 2022-06-27

Lead Sponsor: Shanghai Mental Health Center

Target Recruit Count: 50

Registration Number: NCT03430596

Locations: 🇨🇳
Shanghai Mental Health Center, Shanghai, Shanghai, China

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

Phase 3

Completed

Conditions: Parkinson Disease
Early Parkinson's Disease

Interventions: Drug: P2B001 0.6/0.75 mg
Drug: Pramipexole 0.6 mg
Drug: Marketed Pramipexole ER
Drug: Rasagiline 0.75 mg

First Posted Date: 2017-11-06

Last Posted Date: 2023-03-21

Lead Sponsor: Pharma Two B Ltd.

Target Recruit Count: 544

Registration Number: NCT03329508

Locations: 🇺🇸
P2B001/003 site Boca Raton, Boca Raton, Florida, United States
🇺🇸
P2B001/003 Study site little Rock, Little Rock, Arkansas, United States
🇺🇸
P2B001/003 Site Scottsdale, Scottsdale, Arizona, United States

and more 68 locations

Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: Pramipexole Dexa Medica
Drug: Pramipexole Boehringer Ingelheim Pharma

First Posted Date: 2016-01-21

Last Posted Date: 2016-01-21

Lead Sponsor: Dexa Medica Group

Target Recruit Count: 23

Registration Number: NCT02660060

Locations: 🇮🇩
PT Equilab International, Jakarta, Indonesia

Targeting Cognition in Bipolar Disorder With Pramipexole

Phase 4

Completed

Conditions: Bipolar Disorder

Interventions: Drug: Placebo
Drug: Pramipexole

First Posted Date: 2015-03-25

Last Posted Date: 2020-02-28

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 103

Registration Number: NCT02397837

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
The Zucker Hillside Hospital, Glen Oaks, New York, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States