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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332917

Enrollment

224

Registered

2006-06-02

Start date

2007-02-28

Completion date

2008-07-31

Last updated

2009-01-26

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

Conditions

Early Stage Parkinson's Disease

Keywords

Parkinson's disease

Brief summary

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

Interventions

DRUGPardoprunox

12-42 mg

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 S308.3.001 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

Design outcomes

Primary

Measure	Time frame
Safety: laboratory data, adverse events, vital signs, ECG	24 weeks

Secondary

Measure	Time frame
UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline	24 weeks

Countries

Argentina, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Finland, India, Israel, Mexico, New Zealand, Peru, Romania, Russia, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States

Outcome results

None listed

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