Last updated: 11/04/2018 10:28:29
A Comparison of Ropinirole Immediate Release with Ropinirole Prolonged Release in Patients with Advanced Parkinson’s
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percentage of participants with at least a 20% maintained reduction in Baseline time spent “off” at Week 24 last observation carried forward (LOCF)
Timeframe: Baseline (Week 0) and Week 24
Secondary outcomes:
Mean change from Baseline in percentage awake time spent “off” at Week 24 LOCF
Timeframe: Baseline (Week 0) and 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
Timeframe: Week 24
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
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an “off” state at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
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
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an “off” state at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an “on” state at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an “off” state at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D)
Timeframe: Baseline (Week 0) and Week 24
Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D
Timeframe: Baseline (Week 0) and Week 24
Mean change from Baseline in the total score of the Parkinson’s Disease Sleep Scale (PDSS) at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
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
Timeframe: Baseline (Week 0) and Week 24
Number of participants requiring re-instatement of L-dopa
Timeframe: Week 24
Mean change from baseline in the dose of L-dopa at Week 24 LOCF
Timeframe: Baseline (Week 0) and Week 24
Incidence of all adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to Week 27
Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability
Timeframe: Up to Week 24
Interventions:
Drug: Ropinirole prolonged release
Drug: Ropinirole immediate release
Drug: Placebo
Enrollment:
350
Observational study model:
Not applicable
Primary completion date:
2007-29-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
June 2006 to August 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
Status
Study Complete
Location
GSK Investigational Site
Bristol, Gloucestershire, United Kingdom, BS16 1LE
Status
Study Complete
Location
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA
Status
Study Complete
Location
GSK Investigational Site
Arcugnano (VI), Veneto, Italy, 36057
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Study Complete
Location
GSK Investigational Site
Lido di Camaiore (Lucca), Toscana, Italy, 55043
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33647
Status
Study Complete
Location
GSK Investigational Site
Sant Cugat del Valles (Barcelona), Spain, 08190
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-29-08
Actual study completion date
2007-29-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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