NCT00650104

Brief Summary

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_3 parkinson-disease

Timeline
Completed

Started May 2002

Longer than P75 for phase_3 parkinson-disease

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2010

Completed
Last Updated

May 6, 2013

Status Verified

April 1, 2013

Enrollment Period

6.8 years

First QC Date

March 27, 2008

Results QC Date

February 24, 2010

Last Update Submit

May 2, 2013

Conditions

Parkinson Disease

Keywords

ropinirole IRefficacysafetyopen-labellong term safety; REQUIPropinirole XLropinirole CRParkinson's disease

Outcome Measures

Primary Outcomes (2)

  • Unified Parkinson's Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)

    The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.

    Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78

  • Number of Participants With the Indicated Number of Adverse Events (AEs)

    AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.

    Every study visit from baseline to market availability (Month 78)

Secondary Outcomes (8)

  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)

    Screening; Months 3, 9, 15, 27, and 78

  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)

    Screening; Months 3, 9, 15, 27, and 78

  • Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)

    Screening and Month 78

  • Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)

    Screening and Month 78

  • Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)

    Screening and Month 78

  • +3 more secondary outcomes

Study Arms (1)

Active

ACTIVE COMPARATOR

Open label medication - Ropinirole CR

Drug: Ropinirole XL (formerly CR)

Interventions

Ropinirole XL (formerly CR)DRUG

Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.

Active

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or non-pregnant/non-breast feeding females
  • At least 30 years of age
  • Diagnosis of idiopathic Parkinson''s disease (Hoehn \& Yahr criteria)
  • Completed either Study 167 or Study 164

You may not qualify if:

  • Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
  • Dizziness or fainting due to orthostatic hypotension on standing
  • Significant sleep disorder
  • Drug abuse or alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Scottsdale, Arizona, 85259, United States

Location

GSK Investigational Site

Los Angeles, California, 90033, United States

Location

GSK Investigational Site

Oxnard, California, 93030, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Tampa, Florida, 33606, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160, United States

Location

GSK Investigational Site

Edison, New Jersey, 08818, United States

Location

GSK Investigational Site

Upland, Pennsylvania, 19013, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Hauser RA, Reichmann H, Lew M, Asgharian A, Makumi C, Shulman KJ. Long-term, open-label study of once-daily ropinirole prolonged release in early Parkinson's disease. Int J Neurosci. 2011 May;121(5):246-53. doi: 10.3109/00207454.2010.546538. Epub 2011 Jan 19.

    PMID: 21244307BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

May 1, 2002

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 6, 2013

Results First Posted

April 21, 2010

Record last verified: 2013-04

Locations

US(10)