Status:

COMPLETED

SLV308 for Treatment of Patients With Early Parkinson's Disease

Lead Sponsor:

Solvay Pharmaceuticals

Conditions:

Early Stage Parkinson's Disease

Eligibility:

All Genders

30+ years

Phase:

PHASE3

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 exten...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

468 Patients enrolled

Trial Details

Trial ID

NCT00269516

Start Date

June 1 2006

End Date

December 1 2007

Last Update

August 29 2008

Active Locations (128)

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Page 1 of 32 (128 locations)

1

Site 284

Huntsville, Alabama, United States

2

Site 274

Little Rock, Arkansas, United States

3

Site 283

Fountain Valley, California, United States

4

Site 277

La Jolla, California, United States