Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00134251
First received: August 22, 2005
Last updated: January 29, 2009
Last verified: January 2009

August 22, 2005
January 29, 2009
October 2005
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Complete list of historical versions of study NCT00134251 on ClinicalTrials.gov Archive Site
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Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Parkinson's Disease
Drug: SLV308
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Patients who have signed an informed consent; diagnosis of idiopathic PD.
  • Presence of recognizable "on" and "off" stages
  • Minimum hours of "off" time per day of 2.5 hours
  • Able to keep diaries.

Exclusion Criteria:

  • Unclear diagnosis or a suspicion of other parkinsonian syndromes
  • Have undergone surgical treatment for PD
  • History of non-response to L-dopa.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Malta,   Serbia
 
NCT00134251
S308.3.005, EuDract no 2005-002432-10
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Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP