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

Solvay Pharmaceuticals224 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Early Stage Parkinson's Disease

Interventions

PardoprunoxDRUG

12-42 mg

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (130)

Outcomes

Primary Outcomes

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

Time frame: 24 weeks

Secondary Outcomes

UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline

Time frame: 24 weeks

Data from ClinicalTrials.gov

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Site 284

Huntsville, Alabama, United States

Site 274

Little Rock, Arkansas, United States

Site 283

Fountain Valley, California, United States

Site 277

La Jolla, California, United States

Site 271

San Francisco, California, United States

Site 279

Fort Lauderdale, Florida, United States

Site 293

Gainsville, Florida, United States

Site 282

Port Charlotte, Florida, United States

Site 285

Sunrise, Florida, United States

Site 273

Tampa, Florida, United States

...and 120 more locations