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.
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ClinicalTrials.gov Identifier: NCT00903838
Recruitment Status :
(The study was terminated on 31 May, 2011, due to strategic considerations.)
This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.
Condition or disease
Advanced Stage Parkinson's Disease
Drug: pardoprunoxDrug: pramipexole
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
30 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
Diagnosis is unclear or a suspicion of other parkinsonian syndromes
Patients who have undergone surgery for the treatment of PD