Parkinson's Disease
Conditions
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: 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.
Interventions
DRUGComtess®
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: | — |
| - Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater | — |
| - comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater | — |
| - comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters | — |
| - comparison of the results of the disease specific questionnaire PDQ-39 | — |
| Secondary objectives: | — |
| - comparison of ON-time | — |
| - comparison of proportion of ON-time | — |
| - comparison of daily levodopa doses and total amount of levodopa | — |
| - comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone | — |
| - comparison of clinical global evaluation performed by patient | — |
| - comparison of the tolerability measured as adverse drug reactions in the course of the study | — |
Countries
Germany
Outcome results
None listed