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

NCT00331149 | Completed Phase 3

• 1 other identifier: ROP105323
• Study Type: interventional
• Target: 343
• Locations: 14 countries
• Sites: 81

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

Conditions

Parkinson Disease

Keywords

safety; efficacy; L-dopa; ropinirole PR; Parkinson's disease; ropinirole IR; adjunctive therapy; superiority; REQUIP; health outcomes

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)

  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.

  Baseline (Week 0) and Week 24

Secondary Outcomes (16)

• Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF

  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

  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

  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

  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

  Baseline (Week 0) and Week 24

Interventions

Ropinirole prolonged release DRUG

ropinirole immediate release DRUG

Also known as: Ropinirole prolonged release

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (81)

GSK Investigational Site

Sofia, 1113, Bulgaria

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GSK Investigational Site

Sofia, 1527, Bulgaria

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GSK Investigational Site

Varna, 9010, Bulgaria

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GSK Investigational Site

Halifax, Nova Scotia, B3J 3T1, Canada

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GSK Investigational Site

Ottawa, Ontario, K1G 4G3, Canada

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GSK Investigational Site

Toronto, Ontario, M5T 2S8, Canada

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GSK Investigational Site

Windsor, Ontario, N8X 5A6, Canada

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GSK Investigational Site

Québec, G1R 3X5, Canada

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GSK Investigational Site

Brno, 625 00, Czechia

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GSK Investigational Site

Ostrava - Poruba, 708 52, Czechia

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GSK Investigational Site

Pardubice, 535 03, Czechia

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GSK Investigational Site

Prague, 120 00, Czechia

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GSK Investigational Site

Prague, 150 18, Czechia

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GSK Investigational Site

Aix-en-Provence, 13616, France

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GSK Investigational Site

Clermont-Ferrand, 63003, France

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GSK Investigational Site

Dijon, 21000, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Marseille, 13385, France

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GSK Investigational Site

Paris, 75674, France

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GSK Investigational Site

Munich, Bavaria, 80331, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90402, Germany

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GSK Investigational Site

Unterhaching, Bavaria, 82008, Germany

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GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

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GSK Investigational Site

Hildesheim, Lower Saxony, 31134, Germany

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GSK Investigational Site

Westerstede, Lower Saxony, 26655, Germany

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GSK Investigational Site

Bielefeld, North Rhine-Westphalia, 33647, Germany

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GSK Investigational Site

Dresden, Saxony, 01097, Germany

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GSK Investigational Site

Gera, Thuringia, 07551, Germany

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GSK Investigational Site

Berlin, 10178, Germany

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GSK Investigational Site

Berlin, 12163, Germany

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GSK Investigational Site

Budapest, 1021, Hungary

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GSK Investigational Site

Budapest, 1135, Hungary

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GSK Investigational Site

Debrecen, 4012, Hungary

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GSK Investigational Site

Szeged, 6725, Hungary

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GSK Investigational Site

Chieti Scalo, Abruzzo, 66013, Italy

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GSK Investigational Site

Napoli, Campania, 80131, Italy

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GSK Investigational Site

Rome, Lazio, 00148, Italy

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GSK Investigational Site

Rome, Lazio, 00163, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Milan, Lombardy, 20126, Italy

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GSK Investigational Site

Milan, Lombardy, 20133, Italy

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GSK Investigational Site

Milan, Lombardy, 20142, Italy

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GSK Investigational Site

Grosseto, Tuscany, 58100, Italy

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GSK Investigational Site

Lido Di Camaiore (Lucca), Tuscany, 55043, Italy

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GSK Investigational Site

Arcugnano (VI), Veneto, 36057, Italy

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GSK Investigational Site

Gdansk, 80-299, Poland

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GSK Investigational Site

Katowice, 40-752, Poland

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GSK Investigational Site

Krakow, 31-530, Poland

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GSK Investigational Site

Lublin, 20-718, Poland

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GSK Investigational Site

Poznan, 61-298, Poland

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GSK Investigational Site

Warsaw, 02-097, Poland

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GSK Investigational Site

Bucharest, 11241, Romania

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GSK Investigational Site

Cluj-Napoca, 400012, Romania

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GSK Investigational Site

Moscow, 117049, Russia

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GSK Investigational Site

Moscow, 117593, Russia

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GSK Investigational Site

Moscow, 119881, Russia

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GSK Investigational Site

Moscow, 125101, Russia

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GSK Investigational Site

Moscow, 125367, Russia

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GSK Investigational Site

Saint Petersburg, 194291, Russia

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GSK Investigational Site

Saint Petersburg, 194354, Russia

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GSK Investigational Site

Saint Petersburg, 197022, Russia

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GSK Investigational Site

Pretoria, Gauteng, 0040, South Africa

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GSK Investigational Site

Bloemfontein, 9301, South Africa

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GSK Investigational Site

Cape Town, 7925, South Africa

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GSK Investigational Site

Sunninghill, 2157, South Africa

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GSK Investigational Site

Alcorcon (Madrid), 28922, Spain

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GSK Investigational Site

Barcelona, 08025, Spain

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GSK Investigational Site

Donostia / San Sebastian, 20011, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Sant Cugat Del Valles (Barcelona), 08190, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Seville, 41071, Spain

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GSK Investigational Site

Kyiv, 01021, Ukraine

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GSK Investigational Site

Kyiv, 04114, Ukraine

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GSK Investigational Site

Poltava, 36024, Ukraine

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GSK Investigational Site

Vinnitsa, 21005, Ukraine

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GSK Investigational Site

Bristol, Gloucestershire, BS16 1LE, United Kingdom

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GSK Investigational Site

Stoke-on-Trent, Staffordshire, ST4 7PA, United Kingdom

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GSK Investigational Site

Chertsey, KT16 0QA, United Kingdom

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GSK Investigational Site

Leigh, WN7 1HS, United Kingdom

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GSK Investigational Site

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: June 20, 2006
• Primary Completion: August 29, 2007
• Study Completion: August 29, 2007
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

CZ (5); GB (5); BU (3); FR (6); RU (8); ES (7); DE (11); HU (4); PL (6); RO (2); UA (4); ZA (4); CA (5); IT (11)