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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00381472
First Posted: September 27, 2006
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: Ropinirole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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
Study Completion Date: December 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381472


  Show 76 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
B P Hersh, S A Factor, L Giorgi Ropinirole 24-hour prolonged release improves motor function and activities of daily living as an adjunct to L-dopa in Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2: 13/S2-P2202
F Stocchi, B Hersh, N Earl, B Scott Safety and tolerability of ropinirole 24-hour prolonged release in patients with early and advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S572/P894.
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
Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release. Parkinsons Dis. 2011;2011:354760. doi: 10.4061/2011/354760. Epub 2011 May 11.
Ray Chaudhuri K, Martinez-Martin P, Rolfe KA, Cooper J, Rockett CB, Giorgi L, Ondo WG. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease. Eur J Neurol. 2012 Jan;19(1):105-13. doi: 10.1111/j.1468-1331.2011.03442.x. Epub 2011 Jun 23.
K Sethi, N Earl, R Hauser Ropinirole 24-hour prolonged release improves disease-specific and global symptoms when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S570/P887
M A Stacy, K D Sethi, N L Earl Ropinirole 24-hour prolonged release improves sleep but does not increase daytime sleepiness when used as adjunctive therapy in patients with Parkinson's Disease not optimally controlled by L-dopa. Movement Disorders, November 2006 S15/9.21:1543-1559
M Stacy, R Pahwa, N Earl Ropinirole 24-hour prolonged release reduces "off" time and reduces the need for L-dopa when used as adjunctive therapy in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S596/P972
R A Hauser, M A Stacy, B P Hersh Ropinirole 24 hour prolonged release reduces off time and improves depression when used as adjunctive therapy in patients with Parkinson's disease not optimally controlled with L-dopa Movement Disorders S15-21-P8
R Pahwa, F Stocchi, M A Stacy Ropinirole 24-hour prolonged release is effective in sparing L-dopa dose and improving symptoms as adjuctive therapy in Parkinson's Disease. Eur J Neurol, September 2005/Suppl 2:s2-P2203
R Pahwa, M Stacy, E Elmer, S Isaacson Ropinirole 24-hour prolonged release provides efficacy as early as Week 2 when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S595/P968.
Pahwa R, Stacy MA, Factor SA, Lyons KE, Stocchi F, Hersh BP, Elmer LW, Truong DD, Earl NL; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007 Apr 3;68(14):1108-15.
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
R Pahwa, SA Factor, L Elmer Ropinirole 24 hour prolonged release reduces "off" time in patients with Parkinson's disease not optimally controlled with L-dopa. Eur J Neurol, September 2006/Suppl2, 13/s2:P2154.

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 101468/169
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00381472     History of Changes
Other Study ID Numbers: 101468/169
First Submitted: September 26, 2006
First Posted: September 27, 2006
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
Ropinirole
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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