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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134251

Locations
Bulgaria
Site 16
Plovdiv, Bulgaria
Site 11
Sofia, Bulgaria
Site 12
Sofia, Bulgaria
Site 13
Sofia, Bulgaria
Site 15
Sofia, Bulgaria
Site 14
Sofia, Bulgaria
Malta
Site 21
Guardamangia, Malta
Serbia
Site 34
Belgrade, Serbia
Site 31
Belgrade, Serbia
Site 33
Nis, Serbia
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov 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
Health Authority: Bulgaria: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Malta: Ministry of Health

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

ClinicalTrials.gov processed this record on May 22, 2013