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
• 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

• Parkinson Disease
• Parkinson's Disease

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,