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NCT01485172 · ClinicalTrials.gov registry record · Phase 4
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 186
- Enrollment target
NCT01485172: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01485172 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 186 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485172, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 186 participants
- Enrollment target
Study Summary
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK\&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.
Primary Outcome
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The chan
Interventions
- DRUG ropinirole monotherapy
- DRUG placebo monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2012-01-31 |
| Est. Completion | 2014-04-30 |
| Phase | Phase 4 |
What the finished NCT01485172 record still lists
NCT01485172 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which ropinirole monotherapy is the first listed.
NCT01485172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01485172 about?
NCT01485172 is a clinical study titled "A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease". This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg...
What is the current status of trial NCT01485172?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 186 participants. The study started on 2012-01-31. Estimated completion is 2014-04-30.
What interventions are being tested in trial NCT01485172?
The interventions under investigation include: ropinirole monotherapy (DRUG), placebo monotherapy (DRUG).
Who is sponsoring clinical trial NCT01485172?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01485172's enrollment target sits among peer trials
186 459th of 2000 higher than 1,541 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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