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.

Advanced Stage Parkinson's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double Blind, Pramipexole Controlled 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00903838
• Other study ID #: S308.2.008
• Secondary ID: 2008-000400-81
• Status: Terminated
• Phase: Phase 2
• First received: May 14, 2009
• Last updated: August 25, 2011
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria

• Patients who have signed informed consent

• Diagnosis of idiopathic Parkinson's Disease

• Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization

• Presence of a recognizable ON and OFF state (motor fluctuations)

• Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries

• Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries

• Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 >= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 >=2)

Exclusion Criteria

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes

• Patients who have undergone surgery for the treatment of PD

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Stage Parkinson's Disease
• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• pardoprunox
1.5 to 12 mg/day
• pramipexole
0.75-4.5 mg/day

Locations

Country	Name	City	State
Germany	Site Reference ID/Investigator# 45433	Goettingen
Germany	Site Reference ID/Investigator# 45428	Kassel
Germany	Site Reference ID/Investigator# 45422	Tuebingen
Germany	Site Reference ID/Investigator# 45427	Ulm
Italy	Site Reference ID/Investigator# 45435	Cassino
Italy	Site Reference ID/Investigator# 45436	Chieti Scalo
Italy	Site Reference ID/Investigator# 45437	Rome
Portugal	Site Reference ID/Investigator# 45438	Coimbra
Portugal	Site Reference ID/Investigator# 45439	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Countries where clinical trial is conducted

Germany,  Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in ON-time without dyskinesia		16 weeks	No
Secondary	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	No