Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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: screening visit followed by 5 visits. Approximately 300 patients altogether in up to 25 active German study centres and up to 3 active Lithuanian study centres will be randomised.

• Phase: Phase 4

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Cabergoline; Entacapone; Levodopa

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)