Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

NCT00381472 | Completed Phase 3

• 1 other identifier: 101468/169
• Study Type: interventional
• Target: 393
• Locations: 9 countries
• Sites: 76

Brief Summary

The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Dyskinesia; Adjunctive Therapy with L-dopa

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).

Secondary Outcomes (5)

• Mean change from baseline in:

• amount and percent of awake time spent "on"

• percent awake time spent "off"

• Unified Parkinson's Disease Rating Scale (UPDRS) total motor score

• UPDRS Activities of Daily Living score

Interventions

Ropinirole DRUG

Eligibility Criteria

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

You may qualify if:

• Idiopathic Parkinson's disease
• Modified Hoehn and Yahr Scale Stages II - IV
• Stable dose of L-dopa for at least 4 weeks prior to screening.
• Lack of control with L-dopa therapy.
• Women of child-bearing potential must use a clinically accepted form of birth control.

You may not qualify if:

• Significant and/or uncontrolled medical conditions (excluding Parkinson's disease) within 3 months of screening.
• Any abnormality, at screening, that is considered clinically relevant by the Investigator.
• Dementia
• Use of dopamine agonists within 4 weeks of screening visit.
• Participation in other investigational drug studies.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (76)

GSK Investigational Site

Birmingham, Alabama, 35294-2041, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

San Francisco, California, 94109, United States

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GSK Investigational Site

Englewood, Colorado, 80110, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33486, United States

Location

GSK Investigational Site

Panama City, Florida, 32405, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Tampa, Florida, 33606, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30329, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Glenview, Illinois, 60025, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

GSK Investigational Site

Southfield, Michigan, 48034, United States

Location

GSK Investigational Site

Traverse City, Michigan, 49684, United States

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GSK Investigational Site

Las Vegas, Nevada, 89102, United States

Location

GSK Investigational Site

Albany, New York, 12205, United States

Location

GSK Investigational Site

New York, New York, 10029-6574, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27607, United States

Location

GSK Investigational Site

Toledo, Ohio, 43614-5809, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Upland, Pennsylvania, 19013, United States

Location

GSK Investigational Site

Wichita Falls, Texas, 76301, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53233, United States

Location

GSK Investigational Site

Antwerp, 2020, Belgium

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Hasselt, 3500, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Roeselare, 8800, Belgium

Location

GSK Investigational Site

Brno, 656 91, Czechia

Location

GSK Investigational Site

Hradec Králové, 500 05, Czechia

Location

GSK Investigational Site

Ostrava, 703 52, Czechia

Location

GSK Investigational Site

Ostrava, 710 00, Czechia

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GSK Investigational Site

Pardubice, 535 03, Czechia

Location

GSK Investigational Site

Pilsen, 30460, Czechia

Location

GSK Investigational Site

Prague, 100 34, Czechia

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GSK Investigational Site

Prague, 120 00, Czechia

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GSK Investigational Site

Prague, 128 08, Czechia

Location

GSK Investigational Site

Aix-en-Provence, 13090, France

Location

GSK Investigational Site

Lille, 59037, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Poitiers, 86021, France

Location

GSK Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Budapest, 1083, Hungary

Location

GSK Investigational Site

Budapest, 1096, Hungary

Location

GSK Investigational Site

Budapest, 1135, Hungary

Location

GSK Investigational Site

Budapest, 1145, Hungary

Location

GSK Investigational Site

Budapest, 1204, Hungary

Location

GSK Investigational Site

Miskolc, 3526, Hungary

Location

GSK Investigational Site

Miskolc, 3529, Hungary

Location

GSK Investigational Site

Pécs, 7623, Hungary

Location

GSK Investigational Site

Vasvari Pal Street 2, H=9023 Gyor, Hungary

Location

GSK Investigational Site

Pozzilli (IS), Molise, 86077, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10100, Italy

Location

GSK Investigational Site

Grosseto, Tuscany, 58100, Italy

Location

GSK Investigational Site

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

Location

GSK Investigational Site

Vicenza, Veneto, 36057, Italy

Location

GSK Investigational Site

Bialystok, 15-276, Poland

Location

GSK Investigational Site

Cibórz, 66-212, Poland

Location

GSK Investigational Site

Gdansk, 80-211, Poland

Location

GSK Investigational Site

Gdansk, 80-308, Poland

Location

GSK Investigational Site

Katowice, 40-752, Poland

Location

GSK Investigational Site

Krakow, 31-530, Poland

Location

GSK Investigational Site

Leszno, 64-100, Poland

Location

GSK Investigational Site

Lublin, 20-718, Poland

Location

GSK Investigational Site

Lublin, 20-954, Poland

Location

GSK Investigational Site

Szwajcarska 3, 61-285 Poznań Ul., Poland

Location

GSK Investigational Site

Torun, 87-100, Poland

Location

GSK Investigational Site

Warsaw, 01-337, Poland

Location

GSK Investigational Site

Warsaw, 02-097, Poland

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

Related Publications (14)

• B P Hersh, S A Factor, L Giorgi Ropinirole 24-hour prolonged release improves motor function and activities of daily living as an adjunct to L-dopa in Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2: 13/S2-P2202

  BACKGROUND

• F Stocchi, B Hersh, N Earl, B Scott Safety and tolerability of ropinirole 24-hour prolonged release in patients with early and advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S572/P894.

  BACKGROUND

• F Stocchi, M A Stacy, L Giorgi, N L Earl Safety and tolerability of ropinirole 24-hour prolonged release as adjuctive therapy to L-dopa in patients with Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2-13/a2P2201

  BACKGROUND

• Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release. Parkinsons Dis. 2011;2011:354760. doi: 10.4061/2011/354760. Epub 2011 May 11.

  PMID: 21687750 BACKGROUND

• Ray Chaudhuri K, Martinez-Martin P, Rolfe KA, Cooper J, Rockett CB, Giorgi L, Ondo WG. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease. Eur J Neurol. 2012 Jan;19(1):105-13. doi: 10.1111/j.1468-1331.2011.03442.x. Epub 2011 Jun 23.

  PMID: 21699627 BACKGROUND

• K Sethi, N Earl, R Hauser Ropinirole 24-hour prolonged release improves disease-specific and global symptoms when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S570/P887

  BACKGROUND

• M A Stacy, K D Sethi, N L Earl Ropinirole 24-hour prolonged release improves sleep but does not increase daytime sleepiness when used as adjunctive therapy in patients with Parkinson's Disease not optimally controlled by L-dopa. Movement Disorders, November 2006 S15/9.21:1543-1559

  BACKGROUND

• M Stacy, R Pahwa, N Earl Ropinirole 24-hour prolonged release reduces "off" time and reduces the need for L-dopa when used as adjunctive therapy in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S596/P972

  BACKGROUND

• R A Hauser, M A Stacy, B P Hersh Ropinirole 24 hour prolonged release reduces off time and improves depression when used as adjunctive therapy in patients with Parkinson's disease not optimally controlled with L-dopa Movement Disorders S15-21-P8

  BACKGROUND

• R Pahwa, F Stocchi, M A Stacy Ropinirole 24-hour prolonged release is effective in sparing L-dopa dose and improving symptoms as adjuctive therapy in Parkinson's Disease. Eur J Neurol, September 2005/Suppl 2:s2-P2203

  BACKGROUND

• R Pahwa, M Stacy, E Elmer, S Isaacson Ropinirole 24-hour prolonged release provides efficacy as early as Week 2 when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S595/P968.

  BACKGROUND

• Pahwa R, Stacy MA, Factor SA, Lyons KE, Stocchi F, Hersh BP, Elmer LW, Truong DD, Earl NL; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007 Apr 3;68(14):1108-15. doi: 10.1212/01.wnl.0000258660.74391.c1.

  PMID: 17404192 BACKGROUND

• R Pahwa, S Factor, L Elmer Ropinirole 24 hour prolonged release reduces awake time spent "off" in patients with Parkinson's disease not optimally controlled with L-dopa. Neurology, April 2006. 66 (Suppl 2): A292. P05.135

  BACKGROUND

• R Pahwa, SA Factor, L Elmer Ropinirole 24 hour prolonged release reduces "off" time in patients with Parkinson's disease not optimally controlled with L-dopa. Eur J Neurol, September 2006/Suppl2, 13/s2:P2154.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: June 1, 2003
• Study Completion: December 1, 2004
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

HU (9); BE (5); CZ (9); DE (2); IT (5); ES (1); US (28); PL (13); FR (4)