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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335374

Enrollment

202

Registered

2006-06-09

Start date

2007-08-31

Completion date

2008-11-30

Last updated

2009-02-06

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 S308.3.003 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 S308.3.003 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

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

Australia, Czechia, Estonia, Germany, India, Italy, Lithuania, Malaysia, Netherlands, Poland, Portugal, South Africa, Taiwan, Thailand, United States

Outcome results

None listed

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