Clinical trial NCT00331149: A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: safety
efficacy
L-dopa
ropinirole PR
Parkinson's disease
ropinirole IR
adjunctive therapy
superiority
REQUIP
health outcomes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 343
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: 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:
measure: Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF
timeFrame: Baseline (Week 0) and Week 24
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D
timeFrame: Baseline (Week 0) and Week 24
measure: 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
measure: 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
measure: Percentage of participants requiring re-instatement of L-dopa
timeFrame: Week 24
measure: Mean change from baseline in the dose of L-dopa at Week 24 LOCF
timeFrame: Baseline (Week 0) and Week 24
measure: Incidence of all adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to Week 27
measure: 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
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Québec
country: Canada
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Ostrava - Poruba
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Praha 5
country: Czechia
facility: GSK Investigational Site
city: Aix en Provence
country: France
facility: GSK Investigational Site
city: Clermont Ferrand
country: France
facility: GSK Investigational Site
city: Dijon
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Paris Cedex 14
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Unterhaching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Achim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Westerstede
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Gera
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Szeged
country: Hungary
facility: GSK Investigational Site
city: Chieti Scalo
country: Italy
facility: GSK Investigational Site
state: Abruzzo
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Grosseto
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Lido di Camaiore (Lucca)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Arcugnano (VI)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warsaw
country: Poland
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Cluj Napoca
country: Romania
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Sunninghill
country: South Africa
facility: GSK Investigational Site
city: Alcorcon (Madrid)
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastian
country: Spain
facility: GSK Investigational Site
city: Sant Cugat del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Poltava
country: Ukraine
facility: GSK Investigational Site
city: Vinnitsa
country: Ukraine
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
state: Gloucestershire
city: Stoke-on-Trent
country: United Kingdom
facility: GSK Investigational Site
state: Staffordshire
city: Chertsey
country: United Kingdom
facility: GSK Investigational Site
city: Leigh
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: