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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)

Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome

Phase 3
Completed
Conditions
Restless Legs Syndrome
First Posted Date
2005-09-05
Last Posted Date
2013-11-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
58
Registration Number
NCT00144209
Locations
🇨🇭

Boehringer Ingelheim Investigational Site, Zurzach, Switzerland

Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2005-09-05
Last Posted Date
2014-03-14
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
246
Registration Number
NCT00144300
Locations
🇺🇸

248.538.00010 Boehringer Ingelheim Investigational Site, New York, New York, United States

🇺🇸

248.538.00013 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

🇺🇸

248.538.00006 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

and more 18 locations

Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

Phase 3
Completed
Conditions
Restless Legs Syndrome
First Posted Date
2005-08-23
Last Posted Date
2013-11-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
345
Registration Number
NCT00133198
Locations
🇺🇸

Metrohealth Medical Center, Cleveland, Ohio, United States

🇺🇸

Mid America NeuroScience Institute, Lenexa, Kansas, United States

🇺🇸

HealthQuest Clinical Trials Research, San Diego, California, United States

and more 39 locations

Neuromodulation and Language Acquisition (Stage Ib)

Phase 4
Suspended
Conditions
Healthy
First Posted Date
2005-02-04
Last Posted Date
2010-06-24
Lead Sponsor
University Hospital Muenster
Target Recruit Count
60
Registration Number
NCT00102856
Locations
🇩🇪

Dept. of Neurology, University Hospital Muenster, Muenster, Nordrhein-Westfalen, Germany

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson Disease
Parkinsonian Syndrome
First Posted Date
2004-11-15
Last Posted Date
2010-09-29
Lead Sponsor
Institute for Neurodegenerative Disorders
Target Recruit Count
112
Registration Number
NCT00096720
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

🇺🇸

Lahey Clinic Medical Center, Burlington, Massachusetts, United States

and more 10 locations

Lexapro and Pramipexole and to Treat Major Depression

Phase 2
Completed
Conditions
Major Depression
Interventions
First Posted Date
2004-06-30
Last Posted Date
2013-01-28
Lead Sponsor
National Institute of Mental Health (NIMH)
Target Recruit Count
39
Registration Number
NCT00086307
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Clinical Trial of Pramipexole in Bipolar Depression

Phase 2
Completed
Conditions
Bipolar Disorder
First Posted Date
2001-10-25
Last Posted Date
2008-03-04
Lead Sponsor
National Institute of Mental Health (NIMH)
Target Recruit Count
200
Registration Number
NCT00025792
Locations
🇺🇸

National Institute of Mental Health (NIMH), Bethesda, Maryland, United States

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