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

Phase 4

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00247247
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2005-06
• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-01
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-22
• Last Update Posted: 2007-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Orion Pharma GmbH; 🇩🇪 Hamburg, Germany