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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Tolerability of Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing-Off Phenomenon

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Comtess®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Comtess®|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |