Ropinirole
- Generic Name
- Ropinirole
- Brand Names
- Requip
- Drug Type
- Small Molecule
- Chemical Formula
- C16H24N2O
- CAS Number
- 91374-21-9
- Unique Ingredient Identifier
- 030PYR8953
- Background
Ropinirole, also known as ReQuip, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome , . It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome .
In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole .
- Indication
For the treatment of the signs and symptoms of Parkinson's disease and for the treatment of primary moderate-severe restless legs syndrome .
- Associated Conditions
- Idiopathic Parkinson's Disease, Moderate restless legs syndrome (RLS), Parkinson's Disease (PD), Severe restless legs syndrome (RLS)
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
- First Posted Date
- 2012-06-26
- Last Posted Date
- 2012-09-28
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Target Recruit Count
- 48
- Registration Number
- NCT01627847
- Locations
- 🇮🇳
GVK Biosciences Pvt. Ltd, Ameerpet, Hyderabad, Andhra Pradesh, India
Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
- First Posted Date
- 2012-02-22
- Last Posted Date
- 2018-08-13
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 295
- Registration Number
- NCT01536574
- Locations
- 🇨🇳
GSK Investigational Site, Tianjin, China
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Drug: placebo monotherapy
- First Posted Date
- 2011-12-05
- Last Posted Date
- 2018-06-20
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 186
- Registration Number
- NCT01485172
- Locations
- 🇸🇰
GSK Investigational Site, Bratislava, Slovakia
Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
- First Posted Date
- 2011-09-19
- Last Posted Date
- 2018-06-19
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 24
- Registration Number
- NCT01435915
- Locations
- 🇨🇳
GSK Investigational Site, Beijing, China
Cognitive Remediation for Cocaine Dependence
- Conditions
- Cocaine Dependence
- Interventions
- First Posted Date
- 2011-07-13
- Last Posted Date
- 2018-03-29
- Target Recruit Count
- 119
- Registration Number
- NCT01393457
- Locations
- 🇺🇸
Behavioral and Biomedical Sciences Building, Houston, Texas, United States
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
- First Posted Date
- 2011-06-13
- Last Posted Date
- 2018-06-19
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 50
- Registration Number
- NCT01371682
- Locations
- 🇧🇪
GSK Investigational Site, Antwerpen, Belgium
REQUIP RLS Post Marketing Surveillance
- First Posted Date
- 2011-04-01
- Last Posted Date
- 2017-09-12
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 755
- Registration Number
- NCT01327339
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
- First Posted Date
- 2010-06-30
- Last Posted Date
- 2018-08-06
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 347
- Registration Number
- NCT01154166
- Locations
- 🇨🇳
GSK Investigational Site, Tianjin, China
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
- Conditions
- Restless Legs Syndrome
- Interventions
- Drug: Placebo
- First Posted Date
- 2009-10-16
- Last Posted Date
- 2018-08-10
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 34
- Registration Number
- NCT00996944
- Locations
- 🇯🇵
GSK Investigational Site, Tokushima, Japan
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
- First Posted Date
- 2009-09-29
- Last Posted Date
- 2013-09-09
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 82
- Registration Number
- NCT00986245
- Locations
- 🇰🇷
Boramae City Hospital, Seoul, Korea, Republic of
🇰🇷Seoul National University Hospital, Seoul, Korea, Republic of
Drug Development Updates
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