An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Solvay

Status and phase: Completed; Phase 3

Conditions: Advanced Stage Parkinson's Disease

Treatments: Drug: Pardoprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407095

00407095 (Other Grant/Funding Number)

S308.3.007

2006-005183-91 (EudraCT Number)

Details and patient eligibility

About

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Enrollment: 140 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patients who have completed S308.3.002 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 S308.3.002

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pardoprunox