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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134251
First Posted: August 24, 2005
Last Update Posted: January 30, 2009
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.
Information provided by:
Solvay Pharmaceuticals
  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
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00134251


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

ClinicalTrials.gov Identifier: NCT00134251     History of Changes
Other Study ID Numbers: S308.3.005
EuDract no 2005-002432-10
First Submitted: August 22, 2005
First Posted: August 24, 2005
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


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