Status:
COMPLETED
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Parkinson's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the study per subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-planned visits per subject:...
Eligibility Criteria
Inclusion
- patients suffering from idiopathic Parkinson's Disease (PD) with wearing-off phenomenon
- OFF-time per day \>= 60 min after the first ON-period in the morning
- 3-5 daily dosages of standard levodopa/DDC inhibitor
- stable antiparkinsonian treatment 3 weeks prior to the randomisation
Exclusion
- symptomatic parkinsonism
- concomitant treatment with non-selective MAO inhibitors or a selective MAO-A inhibitor while treated with a MAO-B inhibitor already
- concomitant treatment with one of the following catechol-structured drugs: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine
- concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclopramide) or other drugs with antidopaminergic action
- treatment with COMT-inhibitors 4 weeks prior to the randomisation
- treatment with dopamine agonists 4 weeks prior to the randomisation
- known hypersensitivity to ergot derivatives and entacapone
- dementia (MMSE \<= 24)
- depression (Beck Scale \>= 17)
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00247247
Start Date
December 1 2002
End Date
June 1 2005
Last Update
June 25 2007
Active Locations (1)
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1
Orion Pharma GmbH
Hamburg, Germany, 22607 Hamburg