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.

Abbott

Status and phase: Terminated; Phase 2

Conditions: Advanced Stage Parkinson's Disease

Treatments: Drug: pardoprunox; Drug: pramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903838

S308.2.008

2008-000400-81 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: pardoprunox

2

Active Comparator group

Treatment:

Drug: pramipexole