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

Parkinson Disease Clinical Trial

Official title:

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381472
• Other study ID #: 101468/169
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2006
• Last updated: March 21, 2017
• Start date: June 2003
• Est. completion date: December 2004

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Ropinirole

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Roeselare
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Ostrava
Czech Republic	GSK Investigational Site	Ostrava 10
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Plzen
Czech Republic	GSK Investigational Site	Prague
Czech Republic	GSK Investigational Site	Prague
Czech Republic	GSK Investigational Site	Prague
France	GSK Investigational Site	Aix en Provence
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Poitiers Cedex
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Pécs
Hungary	GSK Investigational Site	Vasvari Pal street 2, H=9023 Gyor
Italy	GSK Investigational Site	Grosseto	Toscana
Italy	GSK Investigational Site	Lido Di Camaiore (LU)	Toscana
Italy	GSK Investigational Site	Pozzilli (IS)	Molise
Italy	GSK Investigational Site	Torino	Piemonte
Italy	GSK Investigational Site	Vicenza	Veneto
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Ciborz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Leszno
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Szwajcarska 3
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Warsaw
Poland	GSK Investigational Site	Warszawa
Spain	GSK Investigational Site	Barcelona
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Glenview	Illinois
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Northridge	California
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Southfield	Michigan
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Traverse City	Michigan
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Poland,  Spain, 

References & 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

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.

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

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

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

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

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. — View Citation

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

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

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.

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

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.

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Secondary	Mean change from baseline in:
Secondary	amount and percent of awake time spent "on"
Secondary	percent awake time spent "off"
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
Secondary	UPDRS Activities of Daily Living score

External 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.