A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

Phase 2

Terminated

• Conditions: Advanced Stage Parkinson's Disease
• Interventions: Drug: pardoprunox; Drug: pramipexole

• Registration Number: NCT00903838
• Lead Sponsor: Abbott Products

Brief Summary

This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.

Detailed Description

Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.

Study Timeline

• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Study Start: 2009-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	pardoprunox	-
2	pramipexole	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in ON-time without dyskinesia	16 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ON-time with (troublesome) dyskinesia; OFF-time; UDysRS, UPDRS (part II + III during ON and OFF state) and Part 4	16 weeks

Trial Locations

Locations (9)

Site Reference ID/Investigator# 45435; 🇮🇹 Cassino, Italy

Site Reference ID/Investigator# 45436; 🇮🇹 Chieti Scalo, Italy

Site Reference ID/Investigator# 45422; 🇩🇪 Tuebingen, Germany

Site Reference ID/Investigator# 45428; 🇩🇪 Kassel, Germany

Site Reference ID/Investigator# 45427; 🇩🇪 Ulm, Germany

Site Reference ID/Investigator# 45433; 🇩🇪 Goettingen, Germany

Site Reference ID/Investigator# 45438; 🇵🇹 Coimbra, Portugal

Site Reference ID/Investigator# 45439; 🇵🇹 Lisbon, Portugal

Site Reference ID/Investigator# 45437; 🇮🇹 Rome, Italy