An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00335374
• Date of registration: 08/06/2006
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals
• Public title: An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
• Scientific title: An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
• Date of first enrolment: August 2007
• Target sample size: 202
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00335374
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Czech Republic, Estonia, France, Germany, India, Italy, Lithuania, Malaysia, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Global Clinical Director Solvay
• Affiliation: Solvay Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have completed S308.3.003 trial

Exclusion Criteria:

- Patients with medically relevant abnormal findings (ECG, physical examination, AEs)
at end of the maintenance phase (visit M6, week 24) of study S308.3.003



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Early Stage Parkinson's Disease

Intervention(s)

Drug: Pardoprunox

Primary Outcome(s)

Safety: laboratory data, adverse events, vital signs, ECG [Time Frame: 24 weeks]

Secondary Outcome(s)

UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline [Time Frame: 24 weeks]

Secondary ID(s)

2006-000859-18

S308.3.008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors