An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Solvay

Status and phase: Completed; Phase 3

Conditions: Early Stage Parkinson's Disease

Treatments: Drug: Pardoprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332917

S308.3.006

2006-000858-45

Details and patient eligibility

About

This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.001 trial

Enrollment: 224 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed S308.3.001 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 S308.3.001

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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224 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pardoprunox