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NCT00134251 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00134251
Other study ID # S308.3.005
Secondary ID EuDract no 2005-
Status Completed
Phase Phase 3
First received August 22, 2005
Last updated January 29, 2009
Start date October 2005

Study information
Verified date January 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesMalta: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SLV308

Locations
Country Name City State
Bulgaria Site 16 Plovdiv
Bulgaria Site 11 Sofia
Bulgaria Site 12 Sofia
Bulgaria Site 13 Sofia
Bulgaria Site 14 Sofia
Bulgaria Site 15 Sofia
Malta Site 21 Guardamangia
Serbia Site 31 Belgrade
Serbia Site 34 Belgrade
Serbia Site 33 Nis

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Bulgaria,  Malta,  Serbia, 

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