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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-06-30

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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Comtess®

Intervention Type DRUG

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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Günther Deuschl, Professor

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Christian-Albrechts-Univeristät zu Kiel

Locations

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Orion Pharma GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CAMP

Identifier Type: -

Identifier Source: secondary_id

2939089