Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Secondary objectives: []
- - comparison of the tolerability measured as adverse drug reactions in the course of the study []
- - 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 []
- - comparison of clinical global evaluation performed by patient []
- - 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 []
Eligibility Criteria
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
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orion Pharma GmbH | Hamburg | Germany | 22607 Hamburg |
Sponsors and Collaborators
- Orion Corporation, Orion Pharma
Investigators
- Principal Investigator: Günther Deuschl, Professor, Klinikum der Christian-Albrechts-Univeristät zu Kiel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2939089
- CAMP