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)
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
- First Posted Date
- 2006-05-04
- Last Posted Date
- 2014-05-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 535
- Registration Number
- NCT00321854
- Locations
- 🇺🇸
248.595.0102 Boehringer Ingelheim Investigational Site, Traverse City, Michigan, United States
🇺🇸248.595.0103 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
🇮🇹248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa, Pisa, Italy
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
- First Posted Date
- 2006-03-01
- Last Posted Date
- 2014-06-09
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 296
- Registration Number
- NCT00297778
- Locations
- 🇦🇹
248.596.43001 Boehringer Ingelheim Investigational Site, Innsbruck, Austria
🇦🇹248.596.43005 Boehringer Ingelheim Investigational Site, Linz, Austria
🇦🇹248.596.43003 Boehringer Ingelheim Investigational Site, Graz, Austria
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2006-01-12
- Last Posted Date
- 2013-10-31
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 346
- Registration Number
- NCT00275457
- Locations
- 🇦🇹
Univ.-Klinik für Neurologie, Innsbruck, Austria
🇸🇪Boehringer Ingelheim Investigational Site, Örebro, Sweden
🇦🇹Confraternität Privatklinik, Wien, Austria
Pramipexole Conversion to Ropinirole Controlled Release (CR)
- First Posted Date
- 2006-01-11
- Last Posted Date
- 2012-08-24
- Lead Sponsor
- Rajesh Pahwa, MD
- Target Recruit Count
- 61
- Registration Number
- NCT00275275
- Locations
- 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
- Conditions
- Parkinson Disease
- First Posted Date
- 2006-01-10
- Last Posted Date
- 2012-05-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 170
- Registration Number
- NCT00274131
Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease
- Conditions
- Parkinson Disease
- First Posted Date
- 2005-10-18
- Last Posted Date
- 2013-11-03
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 208
- Registration Number
- NCT00240409
- Locations
- 🇨🇳
First Hospital of Beijing University, Beijing, China
🇨🇳Beijing Hospital, Beijing, China
🇨🇳Peking Union Medical College Hospital, Beijing, China
Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2005-10-17
- Last Posted Date
- 2013-11-01
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 109
- Registration Number
- NCT00239486
- Locations
- 🇫🇮
NEURO, Helsinki, Finland
Effectiveness of Pramipexole for Treatment-Resistant Depression
- First Posted Date
- 2005-10-04
- Last Posted Date
- 2012-04-26
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 65
- Registration Number
- NCT00231959
- Locations
- 🇺🇸
Depression Clinical and Research Program, Massachusetts General Hospital, Boston, Massachusetts, United States
A Study in Patients Suffering From Idiopathic Restless Legs Syndrome Who Responded to a Preceding, 6-month Treatment With Open-label Pramipexole Including Titration (0.125, 0.25, 0.5, 0.75 mg Orally q.n.)
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2005-09-12
- Last Posted Date
- 2013-11-19
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 224
- Registration Number
- NCT00152958
- Locations
- 🇩🇪
Clinpharm International GmbH & Co. KG, Berlin (Hellersdorf), Germany
🇩🇪emovis GmbH, Berlin, Germany
🇩🇪Paracelsus-Elena-Klinik, Kassel, Germany
Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2005-09-12
- Last Posted Date
- 2013-10-31
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 41
- Registration Number
- NCT00152997
- Locations
- 🇯🇵
Boehringer Ingelheim Investigational Site, Takatsuki, Osaka, Japan
Drug Development Updates
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