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NCT00381472
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa
Phase 3 trial testing Ropinirole in Parkinson Disease in 393 participants. Completed in 1 December 2004.
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 393 |
| Start date | 1 June 2003 |
| Estimated completion | 1 December 2004 |
| Sites | 76 locations across United States, Belgium, Czechia, France, Germany, Hungary, Italy, Poland |
Drugs / interventions tested
- Ropinirole (ropinirole) — full drug profile →
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
30 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Sponsor's own description
The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release.
Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. · · 2011 · cited 7× · PMID 21687750 · DOI 10.4061/2011/354760
Verify or expand the search:
- PubMed search for NCT00381472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ropinirole
Trials testing the same drug.
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- NCT03708237 — Effectiveness of Ropinirole and Gabapentin for the Treatment of RLS in Patients on Maintenance HD · Phase 2 · terminated
- NCT03038308 — Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole · Phase 1, PHASE2 · completed
- NCT03176966 — Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis · Phase 4 · completed
- NCT01435915 — Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects · Phase 1 · completed
Other recruiting trials for Parkinson Disease
Currently open trials in the same condition.
- NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
- NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
- NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
- NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
- NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00381472 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 21 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00381472.
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