We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00331149
First Posted: May 29, 2006
Last Update Posted: October 12, 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
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
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 last observation carried forward (LOCF) [ Time Frame: Baseline (Week 0) and Week 24 ]
    Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.


Secondary Outcome Measures:
  • Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    Diary cards completed by the Participants was used to assess the duration of "off" and "on" periods. During the Treatment Period 2 24 hour diary cards were completed by the Participants (except for the Baseline Period when four diary cards were completed). The Participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • 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 ]
    The CGI-I global improvement scale allows the investigator to rate the participant's total improvement from beginning the treatment (baseline). The scale was rated as 1-7, from 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse and 7: very much worse. CGI global improvement scale was assessed at Week 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 (and at early withdrawal, if applicable. Higher score indicates worsening and lower score indicates very much improvement. A participant was considered as a CGI-I responder when he/she had a score of (1) Very Much Improved or (2) Much Improved.

  • Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the Baseline values from the on-treatment values. Mean change from Baseline in the total motor score with participants in an "on" state was reported.

  • Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an "off" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values. Mean change from baseline in the total motor score with participants in an "off" state was reported.

  • Mean change from baseline in the total Activities of daily living (ADL) score (part II) of the UPDRS, with participants in an "on" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.

  • Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an "off" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "Off" state was where PD symptoms were not adequately controlled by the drug. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.

  • Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "on" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score )and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "on" state of Parkinson's. Baseline was defined as Week 0 assesment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

  • Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "off" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score)and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "off" state of Parkinson's. Baseline was defined as Week 0 assessment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

  • Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D) [ Time Frame: Baseline (Week 0) and Week 24 ]
    The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Thermometer was a 20-cm Visual Analogue Scale (VAS) anchored at 0: worse imaginable health state and 100: best imaginable health state. Participants were required to indicate how good or bad was their health by marking a line on the scale. The point at which the line crossed the thermometer was taken as the score. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D [ Time Frame: Baseline (Week 0) and Week 24 ]
    The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Utility score was computed from 5 dimensions of health: (mobility, self-care, usual activities, pain/discomfort, anxiety /depression). Each dimension comprised 3 levels (some, moderate, extreme problems), and generated a total of 243 theoretically possible health states. The Utility score was combined scores from 5 dimensions, which valued between -0.594 (representing the worse possible health) and 1 (representing the perfect health). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • Mean change from Baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The PDSS comprised of a series of 15 VAS addressing commonly reported symptoms associated with sleep disturbance in PD. The participant or caregiver completed the scale based on their experiences in the past week. Scores for each item ranged from 0 (representing the most severe) to 10 (the least severe). The maximum score for the PDSS was 150 (participant was free of all symptoms). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • Mean change from Baseline in the total movement severity score of the abnormal involuntary movement scale (AIMS), with participants in an "on" state at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The AIMS was a 12 item, investigator performed assessment of facial and oral movements, extremity movements, trunk movements, global judgments and dental status according to predefined criteria. Items 1-10 were rated on a 5 point severity scale with 0: none to 4: severe. Items 11 and 12 were yes or no items. The AIMS total movement severity score was obtained by summing together the responses to the first seven items and ranged from 0 to 28, with higher scores representing more severe involuntary movement. The AIMS was assessed at Week 0, 12, 24. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • Percentage of participants requiring re-instatement of L-dopa [ Time Frame: Week 24 ]
    Participants were defined as having a re-instatement of L-dopa, if at any point during the on-treatment phase (excluding down-titration), their dose of L-dopa was increased, up to, or above their baseline level. Percentage of participants requiring reinstatement of L-dopa was reported at Week 24.

  • Mean change from baseline in the dose of L-dopa at Week 24 LOCF [ Time Frame: Baseline (Week 0) and Week 24 ]
    The start and stop dates of L-Dopa medication were used to determine the dose being taken on a specific date or at an assessment. The dose recorded on the actual date of assessment was used when reporting the corresponding dose. The total daily dose of L-dopa (mg) was calculated as Unit dose per tablet (mg) * Daily Frequency * No of Tablets per administration. Mean change from baseline in the dose of L-dopa at Week 24 was reported. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.

  • Incidence of all adverse events (AE) and serious adverse events (SAE) [ Time Frame: Up to Week 27 ]
    Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

  • Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability [ Time Frame: Up to Week 24 ]
    There was no specific question in the CRF to capture the reason why participants were unable to titrate weekly during this period, the data on the reason for withdrawal in the CRF was thus evaluated in those participants who withdrew during the forced titration period. Data for the number of participants withdrawn (Yes/No) is presented.


Enrollment: 343
Actual Study Start Date: June 20, 2006
Study Completion Date: August 29, 2007
Primary Completion Date: August 29, 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

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:

  • 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
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): 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
GSK Investigational Site
Québec, Canada, G1R 3X5
Czechia
GSK Investigational Site
Brno, Czechia, 625 00
GSK Investigational Site
Ostrava - Poruba, Czechia, 708 52
GSK Investigational Site
Pardubice, Czechia, 535 03
GSK Investigational Site
Praha 2, Czechia, 120 00
GSK Investigational Site
Praha 5, Czechia, 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
First Submitted: May 26, 2006
First Posted: May 29, 2006
Last Update Posted: October 12, 2017
Last Verified: August 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