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

Phase 3

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00381472
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-12
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in:
amount and percent of awake time spent "on"
Unified Parkinson's Disease Rating Scale (UPDRS) total motor score
percent awake time spent "off"
UPDRS Activities of Daily Living score

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Barcelona, Spain