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A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00331149
First received: May 26, 2006
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

Condition Intervention Phase
Parkinson Disease Drug: Ropinirole prolonged release Drug: ropinirole immediate release Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 LOCF [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • Mean change from baseline in percentage awake time spent "off" at Week 24 LOCF [ Time Frame: Week 24 ]
  • Number of participants with a score of 'much improved' or 'very much improved' on the Clinical Global Impression-global improvement (CGI-I) scale at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total motor score of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total motor score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total ADL score of the UPDRS, with participants in an "on" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total ADL score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Week 24 ]
  • Mean change from baseline in the total score of the UPDRS, with subjects in an "on" state.at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline in the total score of the UPDRS, with subjects in an "off" state.at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D) [ Time Frame: baseline and Week 24 ]
  • Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D. [ Time Frame: baseline and Week 24 ]
  • Mean change from baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF [ Time Frame: Baseline and Week 24 ]
  • Mean change from baseline in the total movement severity score of the Abnormal Involuntary Movement Scale (AIMS), with subjects in an "on" state at Week 24 LOCF [ Time Frame: baseline and Week 24 ]
  • Percentage of participants requiring reinstatement of L-dopa. [ Time Frame: Week 24 ]
  • Mean change from baseline in the dose of L-dopa at Week 24 [ Time Frame: baseline and Week 24 ]

Estimated Enrollment: 344
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ropinirole prolonged release Drug: ropinirole immediate release
    Other Name: Ropinirole prolonged release
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn & Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa.

Exclusion criteria:

  • Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias on a stable dose of L-dopa.
  • Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy.
  • Recent history of severe dizziness or fainting on standing.
  • Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis.
  • Recent history or current evidence of drug abuse or alcoholism.
  • Use of a dopamine agonist within 4 weeks of starting the study.
  • Personal or family history of an allergic reaction to ropinirole.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331149

  Show 81 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00331149     History of Changes
Other Study ID Numbers: ROP105323
Study First Received: May 26, 2006
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline:
safety
efficacy
L-dopa
ropinirole PR
Parkinson's disease
ropinirole IR
adjunctive therapy
superiority
REQUIP
health outcomes

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

ClinicalTrials.gov processed this record on June 22, 2017