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

Solvay Pharmaceuticals140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Advanced Stage Parkinson's Disease

Interventions

PardoprunoxDRUG

12-42 mg/day

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (87)

Outcomes

Primary Outcomes

Safety: laboratory data, adverse events, vital signs, ECG

Time frame: 36 weeks

Secondary Outcomes

On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline

Time frame: 36 weeks

Data from ClinicalTrials.gov

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S308.3.007 Site # 220

La Jolla, California, United States

S308.3.007 Site # 211

San Francisco, California, United States

S308.3.007 Site # 214

Fort Lauderdale, Florida, United States

S308.3.007 Site # 218

Gainsville, Florida, United States

S308.3.007 Site # 213

Tampa, Florida, United States

S308.3.007 Site # 219

Augusta, Georgia, United States

S308.3.007 Site # 221

Chicago, Illinois, United States

S308.3.007 Site # 216

Kansas City, Kansas, United States

S308.3.007 Site # 224

Lexington, Kentucky, United States

S308.3.007 Site # 212

East Lansing, Michigan, United States

...and 77 more locations