MedPath

SLV308 for Treatment of Patients With Early Parkinson's Disease

Phase 3
Completed
Conditions
Early Stage Parkinson's Disease
Interventions
Drug: Placebo
Registration Number
NCT00269516
Lead Sponsor
Solvay Pharmaceuticals
Brief Summary

This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early 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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
468
Inclusion Criteria
  • Diagnosis of idiopathic Parkinson's Disease,
  • Early stage of disease, Modified Hoehn & Yahr up to stage III,
  • UPDRS motor score (part III) 10 at baseline.
Exclusion Criteria
  • Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
  • Patients who have undergone surgery for the treatment of PD,
  • Presence of dyskinesias,
  • Motor fluctuations or loss of postural reflexes,
  • Clinically significant abnormalities,
  • Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
  • Antipsychotic.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Pardoprunox-
2Pardoprunox-
3Pardoprunox-
4Placebo-
Primary Outcome Measures
NameTimeMethod
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment6 months
Secondary Outcome Measures
NameTimeMethod
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment6 months

Trial Locations

Locations (128)

Site 284

🇺🇸

Huntsville, Alabama, United States

Site 274

🇺🇸

Little Rock, Arkansas, United States

Site 283

🇺🇸

Fountain Valley, California, United States

Site 277

🇺🇸

La Jolla, California, United States

Site 271

🇺🇸

San Francisco, California, United States

Site 279

🇺🇸

Ft Lauderdale, Florida, United States

Site 293

🇺🇸

Gainsville, Florida, United States

Site 282

🇺🇸

Port Charlotte, Florida, United States

Site 285

🇺🇸

Sunrise, Florida, United States

Site 273

🇺🇸

Tampa, Florida, United States

Scroll for more (118 remaining)
Site 284
🇺🇸Huntsville, Alabama, United States
© Copyright 2025. All Rights Reserved by MedPath