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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00381472
First received: September 26, 2006
Last updated: July 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Parkinson's Disease
 Drug: Ropinirole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).

Secondary Outcome Measures:
  • Mean change from baseline in:
  • amount and percent of awake time spent "on"
  • percent awake time spent "off"
  • Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
  • UPDRS Activities of Daily Living score

Estimated Enrollment: 393
Study Start Date: June 2003
Intervention Details:
    Drug: Ropinirole
    Other Name: Ropinirole
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381472

  Show 71 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
R Pahwa, S Factor, L Elmer Ropinirole 24 hour prolonged release reduces awake time spent "off" in patients with Parkinson's disease not optimally controlled with L-dopa. Neurology, April 2006. 66 (Suppl 2): A292. P05.135
F Stocchi, M A Stacy, L Giorgi, N L Earl Safety and tolerability of ropinirole 24-hour prolonged release as adjuctive therapy to L-dopa in patients with Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2-13/a2P2201

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00381472     History of Changes
Other Study ID Numbers: 101468/169
Study First Received: September 26, 2006
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Parkinson's Disease
Dyskinesia
Adjunctive Therapy with L-dopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Ropinirole
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists

ClinicalTrials.gov processed this record on May 19, 2013