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)

Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
442
Registration Number
NCT02248181

Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Completed
Conditions
Restless Legs Syndrome
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1029
Registration Number
NCT02248142

Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1293
Registration Number
NCT02248207

Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1449
Registration Number
NCT02248168

Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Completed
Conditions
Restless Legs Syndrome
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2644
Registration Number
NCT02248155

Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-11
Last Posted Date
2014-09-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
497
Registration Number
NCT02236728

The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia

Completed
Conditions
Heart Failure
Interventions
First Posted Date
2014-09-11
Last Posted Date
2014-09-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
26814
Registration Number
NCT02236741

Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-08
Last Posted Date
2014-09-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
705
Registration Number
NCT02233023

Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-04
Last Posted Date
2014-09-17
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1216
Registration Number
NCT02231255
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