Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SLV308
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, adjunctive to L-dopa therapy, Advanced stage Parkinson's disease
Eligibility 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.
Sites / Locations
- Site 16
- Site 11
- Site 12
- Site 13
- Site 14
- Site 15
- Site 21
- Site 31
- Site 34
- Site 33
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00134251
First Posted
August 22, 2005
Last Updated
January 29, 2009
Sponsor
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00134251
Brief Title
Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, adjunctive to L-dopa therapy, Advanced stage Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SLV308
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 16
City
Plovdiv
Country
Bulgaria
Facility Name
Site 11
City
Sofia
Country
Bulgaria
Facility Name
Site 12
City
Sofia
Country
Bulgaria
Facility Name
Site 13
City
Sofia
Country
Bulgaria
Facility Name
Site 14
City
Sofia
Country
Bulgaria
Facility Name
Site 15
City
Sofia
Country
Bulgaria
Facility Name
Site 21
City
Guardamangia
Country
Malta
Facility Name
Site 31
City
Belgrade
Country
Serbia
Facility Name
Site 34
City
Belgrade
Country
Serbia
Facility Name
Site 33
City
Nis
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
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