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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)

The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease

Not Applicable
Completed
Conditions
Idiopathic Parkinson's Disease
Interventions
First Posted Date
2011-11-11
Last Posted Date
2015-10-21
Lead Sponsor
Huashan Hospital
Target Recruit Count
30
Registration Number
NCT01470859
Locations
🇨🇳

Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor

Phase 3
Withdrawn
Conditions
Essential Tremor
Interventions
Drug: placebo
First Posted Date
2011-09-27
Last Posted Date
2017-05-08
Lead Sponsor
University of Pecs
Registration Number
NCT01441284
Locations
🇭🇺

Department of Neurology, University of Pécs, Pécs, Baranya Megye, Hungary

🇭🇺

Kaposi Mór County Hospital, Kaposvár, Somogy Megye, Hungary

a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease Patients

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2011-05-26
Last Posted Date
2014-05-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
2017
Registration Number
NCT01361009
Locations
🇨🇳

Boehringer Ingelheim Investigational Site 52, Suzhou, China

🇨🇳

Boehringer Ingelheim Investigational Site 57, Beijing, China

🇨🇳

Boehringer Ingelheim Investigational Site 60, Beijing, China

and more 100 locations

Minocycline, Acetylsalicylic Acid or Pramipexole vs Placebo in Patients With Schizophrenia or Schizoaffective Disorder

Phase 3
Conditions
Schizophrenia
Schizoaffective Disorder
Interventions
First Posted Date
2011-03-23
Last Posted Date
2011-03-23
Lead Sponsor
Sheba Medical Center
Target Recruit Count
400
Registration Number
NCT01320982
Locations
🇷🇴

Clinica de Psihiatrie, Arad, Romania

🇷🇴

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia", Bucuresti, Romania

🇷🇴

Sp. Jud. "Prof. Dr.O. Fodor", Cluj-Napoca, Romania

and more 4 locations

Multiple Dose Bioequivalence Study of Pramipexole Extended Release in Chinese Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-10-04
Last Posted Date
2014-06-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT01214109
Locations
🇨🇳

248.665.86002 Boehringer Ingelheim Investigational Site, Beijing, China

Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients

Phase 3
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2010-08-31
Last Posted Date
2014-10-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
475
Registration Number
NCT01191944
Locations
🇨🇳

248.671.86013 Boehringer Ingelheim Investigational Site, Chongqing, China

🇨🇳

248.671.86012 Boehringer Ingelheim Investigational Site, Chengdu, China

🇨🇳

248.671.86014 Boehringer Ingelheim Investigational Site, Chongqing, China

and more 17 locations

Pramipexole for Binge Eating Disorder

Phase 3
Withdrawn
Conditions
Binge Eating Disorder
Interventions
First Posted Date
2010-04-19
Last Posted Date
2013-05-06
Lead Sponsor
Neuropsychiatric Research Institute, Fargo, North Dakota
Registration Number
NCT01106053

Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2010-04-01
Last Posted Date
2014-04-11
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
329
Registration Number
NCT01097421

Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-02-24
Last Posted Date
2010-04-30
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
24
Registration Number
NCT01074463
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-02-24
Last Posted Date
2010-04-30
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
24
Registration Number
NCT01074450
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

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