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

Orion Pharma

Status and phase

Completed

Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Comtess®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00247247

2939089

CAMP

Details and patient eligibility

About

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.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)