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

Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Comtess® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Orion Corporation, Orion Pharma

Official(s) and/or principal investigator(s):
Günther Deuschl, Professor, Principal Investigator, Affiliation: Klinikum der Christian-Albrechts-Univeristät zu Kiel

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

- 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)

Locations and Contacts

Orion Pharma GmbH, Hamburg 22607 Hamburg, Germany
Additional Information

Starting date: December 2002
Last updated: June 22, 2007

Page last updated: August 23, 2015

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