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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134251
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : January 30, 2009
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: SLV308 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005

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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134251

Site 16
Plovdiv, Bulgaria
Site 11
Sofia, Bulgaria
Site 12
Sofia, Bulgaria
Site 13
Sofia, Bulgaria
Site 14
Sofia, Bulgaria
Site 15
Sofia, Bulgaria
Site 21
Guardamangia, Malta
Site 31
Belgrade, Serbia
Site 34
Belgrade, Serbia
Site 33
Nis, Serbia
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals Identifier: NCT00134251     History of Changes
Other Study ID Numbers: S308.3.005
EuDract no 2005-002432-10
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Solvay Pharmaceuticals:
Parkinson's disease
adjunctive to L-dopa therapy
Advanced stage Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases