SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

Phase 3

Completed

• Conditions: Advanced Stage Parkinson's Disease
• Interventions: Drug: Levodopa (Pardoprunox); Drug: Placebo Comparator

• Registration Number: NCT00406588
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Study Start: 2007-03
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Status Verified: 2008-07
• Disposition First Submitted: 2015-01-29
• Disposition First Submitted QC: 2015-02-09
• Last Update Submitted: 2015-02-09
• Disposition First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

• Diagnosis of idiopathic Parkinson's Disease,
• advance stage of disease,
• Modified Hoehn & Yahr stage II-IV,
• presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion Criteria

• 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
• Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
• Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
• Previous surgery for the treatment of PD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levodopa (Pardoprunox)	-
2	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39	12 weeks

Trial Locations

Locations (87)

Site 223; 🇺🇸 Birmingham, Alabama, United States

Site 220; 🇺🇸 LaJolla, California, United States

Site 211; 🇺🇸 San Francisco, California, United States

Site 214; 🇺🇸 Fort Lauderdale, Florida, United States

Site 218; 🇺🇸 Gainsville, Florida, United States

Site 213; 🇺🇸 Tampa, Florida, United States

Site 219; 🇺🇸 Augusta, Georgia, United States

Site 221; 🇺🇸 Chicago, Illinois, United States

Site 216; 🇺🇸 Kansas City, Kansas, United States

Site 224; 🇺🇸 Lexington, Kentucky, United States

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