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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00331149
• Date of registration: 26/05/2006
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
• Scientific 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.
• Date of first enrolment: June 20, 2006
• Target sample size: 343
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00331149
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Ropinirole prolonged release

Drug: ropinirole immediate release

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D [Time Frame: Baseline (Week 0) and Week 24]

Incidence of all adverse events (AE) and serious adverse events (SAE) [Time Frame: Up to Week 27]

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]

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]

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]

Percentage of participants requiring re-instatement of L-dopa [Time Frame: 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 [Time Frame: 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) [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline (Week 0) and Week 24]

Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF [Time Frame: Baseline (Week 0) and Week 24]

Mean change from baseline in the dose of L-dopa at Week 24 LOCF [Time Frame: 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 [Time Frame: Baseline (Week 0) and Week 24]

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]

Secondary ID(s)

ROP105323

Source(s) of Monetary Support

Please refer to primary and secondary sponsors