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

Solvay Pharmaceuticals202 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 S308.3.003 trial

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

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 S308.3.003 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

Locations (75)

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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419

Birmingham, Alabama, United States

413

Oceanside, California, United States

408

Oxnard, California, United States

422

New Haven, Connecticut, United States

403

Boca Raton, Florida, United States

411

Sarasota, Florida, United States

421

Augusta, Georgia, United States

410

Fort Wayne, Indiana, United States

417

Lexington, Kentucky, United States

405

Boston, Massachusetts, United States

...and 65 more locations