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OpenTrials
Completed

NCT Number: NCT00381472

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic Parkinson's disease
  • Modified Hoehn and Yahr Scale Stages II - IV
  • Stable dose of L-dopa for at least 4 weeks prior to screening.
  • Lack of control with L-dopa therapy.
  • Women of child-bearing potential must use a clinically accepted form of birth control.

Exclusion criteria

  • Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
  • Any abnormality, at screening, that is considered clinically relevant by the Investigator.
  • Dementia
  • Use of dopamine agonists within 4 weeks of screening visit.
  • Participation in other investigational drug studies.

Treatment and study plan

Ropinirole

Drug

Primary outcomes

  1. Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).

Secondary outcomes

  1. Mean change from baseline in:

  2. amount and percent of awake time spent "on"

  3. percent awake time spent "off"

  4. Unified Parkinson's Disease Rating Scale (UPDRS) total motor score

  5. UPDRS Activities of Daily Living score

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 27, 2006
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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