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NCT01494532 · ClinicalTrials.gov registry record · Phase 4

A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease

A Phase 4 study of Parkinson Disease, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
352
Enrollment target
20
Study locations

NCT01494532 is a Phase 4 study of Parkinson Disease that has completed, run by GlaxoSmithKline. The registered enrollment target is 352 participants, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT01494532, a Phase 4 study of Parkinson Disease, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
352 participants
Enrollment target
20
Study locations

Study Summary

This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

Conditions Studied

Parkinson Disease

Interventions

  • DRUG ropinirole/L-dopa
  • DRUG placebo/L-dopa

Study Locations (20)

Other

  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Caba
  • GSK Investigational Site - Santiago

California

  • GSK Investigational Site - Fountain Valley
  • GSK Investigational Site - Pasadena
  • GSK Investigational Site - Reseda
  • GSK Investigational Site - Ventura

Buenos Aires

  • GSK Investigational Site - Ciudad Autonoma de Buenos Aires
  • GSK Investigational Site - Ciudad Autonoma de Buenos Aires
  • GSK Investigational Site - Ciudad Autónoma de Buenos Aires
  • GSK Investigational Site - San Martín

Florida

  • GSK Investigational Site - Boca Raton
  • GSK Investigational Site - Tampa

Massachusetts

  • GSK Investigational Site - Springfield

New York

  • GSK Investigational Site - Forest Hills

Virginia

  • GSK Investigational Site - Richmond

Los Lagos Region

  • GSK Investigational Site - Valdivia

Trial Details

FieldValue
Enrollment Target 352 participants
Start Date 2012-04-02
Est. Completion 2014-11-18
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT01494532

The ClinicalTrials.gov registry entry for NCT01494532 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (93% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which ropinirole/L-dopa is the first listed.

NCT01494532 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT01494532 about?

NCT01494532 is a clinical study titled "A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease". This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpo...

What is the current status of trial NCT01494532?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 352 participants. The study started on 2012-04-02. Estimated completion is 2014-11-18.

What conditions does trial NCT01494532 study?

This clinical trial studies the following conditions: Parkinson Disease.

What interventions are being tested in trial NCT01494532?

The interventions under investigation include: ropinirole/L-dopa (DRUG), placebo/L-dopa (DRUG).

Who is sponsoring clinical trial NCT01494532?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01494532 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.