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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 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 186 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01485172
The ClinicalTrials.gov registry entry for NCT01485172 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ropinirole monotherapy is the first listed.
NCT01485172 reports 0 study locations.
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.
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