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)
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
- First Posted Date
- 2007-05-11
- Last Posted Date
- 2014-06-27
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 331
- Registration Number
- NCT00472199
- Locations
- 🇬🇧
248.629.44003 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom
🇪🇸248.629.3402 Boehringer Ingelheim Investigational Site, Barcelona, Spain
🇬🇧248.629.44004 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom
Pivotal Study in Advanced Parkinsons Disease Patients
- Conditions
- Parkinson Disease
- Interventions
- First Posted Date
- 2007-04-27
- Last Posted Date
- 2014-07-08
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 517
- Registration Number
- NCT00466167
- Locations
- 🇦🇹
248.525.43005 Boehringer Ingelheim Investigational Site, Linz, Austria
🇰🇷248.525.82008 Boehringer Ingelheim Investigational Site, Kyeonggi-do, Korea, Republic of
🇮🇹248.525.39005 Università La Sapienza di Roma, Roma, Italy
A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
- First Posted Date
- 2006-11-22
- Last Posted Date
- 2014-05-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 312
- Registration Number
- NCT00402233
- Locations
- 🇺🇸
248.622.5 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
🇺🇸248.622.40 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States
🇺🇸248.622.76 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
- Conditions
- Idiopathic Restless Legs Syndrome
- Interventions
- First Posted Date
- 2006-10-20
- Last Posted Date
- 2014-07-02
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 154
- Registration Number
- NCT00390689
- Locations
- 🇯🇵
248.627.031 Boehringer Ingelheim Investigational Site, Urasoe, Okinawa, Japan
🇯🇵248.627.037 Boehringer Ingelheim Investigational Site, Aichi-gun, Aichi, Japan
🇯🇵248.627.023 Boehringer Ingelheim Investigational Site, Kitakyusyu, Fukuoka, Japan
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2006-09-12
- Last Posted Date
- 2013-10-31
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 404
- Registration Number
- NCT00375284
- Locations
- 🇺🇸
248.616.035 Boehringer Ingelheim Investigational Site, Mesa, Arizona, United States
🇺🇸248.616.049 Boehringer Ingelheim Investigational Site, Augusta, Georgia, United States
🇺🇸248.616.066 Boehringer Ingelheim Investigational Site, Savannah, Georgia, United States
Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
- Conditions
- Restless Legs SyndromeDepression
- First Posted Date
- 2006-07-25
- Last Posted Date
- 2012-05-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 404
- Registration Number
- NCT00356096
- Locations
- 🇫🇮
248.604.35801 Boehringer Ingelheim Investigational Site, Espoo, Finland
🇰🇷248.604.82003 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of
🇮🇹248.604.3909 IRCCS Fondazione "Salvatore Maugeri", Telese Terme (be), Italy
A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2006-07-07
- Last Posted Date
- 2012-05-21
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 369
- Registration Number
- NCT00349531
- Locations
- 🇬🇧
248.615.44009 Boehringer Ingelheim Investigational Site, Reading, United Kingdom
🇪🇸248.615.3404 Hospital General Universitario Gregorio Marañón, Madrid, Spain
🇪🇸248.615.3408 Hospital Nuestra Señora de Sonsoles, Avila, Spain
Profile of Depressive Symptoms in Parkinsons Disease
- Conditions
- DepressionParkinson Disease
- First Posted Date
- 2006-07-06
- Last Posted Date
- 2023-12-14
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 1018
- Registration Number
- NCT00349310
- Locations
- 🇫🇷
Hopital Purpan, Toulouse cedex, France
🇬🇧Boehringer Ingelheim Investigational Site, Newark, United Kingdom
🇩🇪Parkinson Klinik Wolfach, Wolfach, Germany
SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
- Conditions
- Restless Legs Syndrome
- First Posted Date
- 2006-06-27
- Last Posted Date
- 2011-05-13
- Lead Sponsor
- Augusta University
- Target Recruit Count
- 20
- Registration Number
- NCT00344994
- Locations
- 🇺🇸
Medical College of Georgia, Augusta, Georgia, United States
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
- Conditions
- Early Stage Parkinson Disease
- Interventions
- First Posted Date
- 2006-06-09
- Last Posted Date
- 2008-04-03
- Lead Sponsor
- Solvay Pharmaceuticals
- Target Recruit Count
- 330
- Registration Number
- NCT00335166
- Locations
- 🇺🇸
418, Albany, New York, United States
🇮🇳336, Mumbai, India
🇵🇱371, Kalisz, Poland
Drug Development Updates
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