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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)

DIalysis Symptom COntrol-Restless Legs Syndrome Trial

Phase 3
Completed
Conditions
Restless Legs Syndrome
End Stage Renal Disease
Interventions
First Posted Date
2019-01-16
Last Posted Date
2022-09-21
Lead Sponsor
Population Health Research Institute
Target Recruit Count
52
Registration Number
NCT03806530
Locations
🇨🇦

The Ottawa Hospital, Ottawa, Ontario, Canada

🇨🇦

St. Joseph's Hamilton Healthcare, Hamilton, Ontario, Canada

🇨🇦

Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD

Phase 2
Terminated
Conditions
Restless Legs Syndrome
End Stage Renal Disease
Interventions
First Posted Date
2018-10-17
Last Posted Date
2022-07-12
Lead Sponsor
University of Alberta
Target Recruit Count
3
Registration Number
NCT03708237
Locations
🇨🇦

Edmonton General Continuing Care Centre, Edmonton, Canada

🇨🇦

Royal Alexandra Hospital, Edmonton, Canada

🇨🇦

Grey Nuns Community Hospital, Edmonton, Canada

and more 1 locations

Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole

Phase 1
Terminated
Conditions
Parkinson Disease
Interventions
First Posted Date
2017-08-15
Last Posted Date
2023-05-06
Lead Sponsor
Titan Pharmaceuticals
Target Recruit Count
6
Registration Number
NCT03250117
Locations
🇺🇸

Orlando, Florida, Orlando, Florida, United States

🇺🇸

Kirkland, Washington, Kirkland, Washington, United States

🇺🇸

Farmington Hills, Michigan, Farmington Hills, Michigan, United States

Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Phase 4
Completed
Conditions
Muscle Cramp
Cirrhosis
Interventions
Other: Muscle cramp survey
First Posted Date
2017-06-06
Last Posted Date
2022-10-31
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
31
Registration Number
NCT03176966
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Phase 1
Completed
Conditions
Hyperprolactinemia
Prolactinoma
Interventions
First Posted Date
2017-01-31
Last Posted Date
2024-06-04
Lead Sponsor
Columbia University
Target Recruit Count
16
Registration Number
NCT03038308
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

First Posted Date
2013-08-27
Last Posted Date
2018-06-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
81
Registration Number
NCT01929317
Locations
🇯🇵

GSK Investigational Site, Shizuoka, Japan

Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions

Phase 1
Completed
Conditions
Pharmacokinetic Study
Interventions
First Posted Date
2012-10-30
Last Posted Date
2012-10-30
Lead Sponsor
Lupin Ltd.
Target Recruit Count
12
Registration Number
NCT01717235
Locations
🇮🇳

Sipra Labs Limited, Hyderabad,, Andhra Pradesh,, India

Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions

Phase 1
Completed
Conditions
Pharmacokinetic Study
Interventions
First Posted Date
2012-10-26
Last Posted Date
2012-10-26
Lead Sponsor
Lupin Ltd.
Target Recruit Count
12
Registration Number
NCT01714856
Locations
🇮🇳

Sipra Labs Limited, Hyderabad, Andhra Pradesh, India

A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients

Phase 3
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2012-06-27
Last Posted Date
2014-05-23
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
420
Registration Number
NCT01628926

Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
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
NCT01627834
Locations
🇮🇳

GVK Biosciences Pvt. Ltd, Ameerpet, Hyderabad, India

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