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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

  Hide Study Locations
Locations
Bulgaria
GSK Investigational Site
Sofia, Bulgaria, 1113
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3J 3T1
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1G 4G3
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
GSK Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
GSK Investigational Site
Québec, Quebec, Canada, G1R 3X5
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 625 00
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
GSK Investigational Site
Pardubice, Czech Republic, 535 03
GSK Investigational Site
Praha 2, Czech Republic, 120 00
GSK Investigational Site
Praha 5, Czech Republic, 150 18
France
GSK Investigational Site
Aix en Provence, France, 13616
GSK Investigational Site
Clermont Ferrand, France, 63003
GSK Investigational Site
Dijon, France, 21000
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Marseille, France, 13385
GSK Investigational Site
Paris Cedex 14, France, 75674
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Nuernberg, Bayern, Germany, 90402
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33647
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Gera, Thueringen, Germany, 07551
GSK Investigational Site
Berlin, Germany, 10178
GSK Investigational Site
Berlin, Germany, 12163
Hungary
GSK Investigational Site
Budapest, Hungary, 1021
GSK Investigational Site
Budapest, Hungary, 1135
GSK Investigational Site
Debrecen, Hungary, 4012
GSK Investigational Site
Szeged, Hungary, 6725
Italy
GSK Investigational Site
Chieti Scalo, Abruzzo, Italy, 66013
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Roma, Lazio, Italy, 00148
GSK Investigational Site
Roma, Lazio, Italy, 00163
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20126
GSK Investigational Site
Milano, Lombardia, Italy, 20133
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Grosseto, Toscana, Italy, 58100
GSK Investigational Site
Lido di Camaiore (Lucca), Toscana, Italy, 55043
GSK Investigational Site
Arcugnano (VI), Veneto, Italy, 36057
Poland
GSK Investigational Site
Gdansk, Poland, 80-299
GSK Investigational Site
Katowice, Poland, 40-752
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Poznan, Poland, 61-298
GSK Investigational Site
Warsaw, Poland, 02-097
Romania
GSK Investigational Site
Bucharest, Romania, 11241
GSK Investigational Site
Cluj Napoca, Romania, 400012
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 117593
GSK Investigational Site
Moscow, Russian Federation, 119881
GSK Investigational Site
Moscow, Russian Federation, 125101
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
St-Petersburg, Russian Federation, 194354
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St.-Petersburg, Russian Federation, 194291
South Africa
GSK Investigational Site
Pretoria, Gauteng, South Africa, 0040
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Cape Town, South Africa, 7925
GSK Investigational Site
Sunninghill, South Africa, 2157
Spain
GSK Investigational Site
Alcorcon (Madrid), Spain, 28922
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
San Sebastian, Spain, 20011
GSK Investigational Site
Sant Cugat del Valles (Barcelona), Spain, 08190
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Sevilla, Spain, 41071
Ukraine
GSK Investigational Site
Kyiv, Ukraine, 01021
GSK Investigational Site
Kyiv, Ukraine, 04114
GSK Investigational Site
Poltava, Ukraine, 36024
GSK Investigational Site
Vinnitsa, Ukraine, 21005
United Kingdom
GSK Investigational Site
Bristol, Gloucestershire, United Kingdom, BS16 1LE
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA
GSK Investigational Site
Chertsey, United Kingdom, KT16 0QA
GSK Investigational Site
Leigh, United Kingdom, WN7 1HS
GSK Investigational Site
Oxford, United Kingdom, OX3 9DU
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 April 28, 2017