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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: August 22, 2005
Last updated: January 29, 2009
Last verified: January 2009
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 Intervention Phase
Parkinson's Disease Drug: SLV308 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: October 2005

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00134251     History of Changes
Other Study ID Numbers: S308.3.005
EuDract no 2005-002432-10
Study First Received: August 22, 2005
Last Updated: January 29, 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 processed this record on September 19, 2017