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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407095

Enrollment

140

Registered

2006-12-04

Start date

2007-08-31

Completion date

2009-05-31

Last updated

2010-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Stage Parkinson's Disease

Keywords

Parkinson Disease

Brief summary

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.

Interventions

DRUGPardoprunox

12-42 mg/day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety: laboratory data, adverse events, vital signs, ECG	36 weeks

Secondary

Measure	Time frame
On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline	36 weeks

Countries

Albania, Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Latvia, Lithuania, Peru, Russia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026