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

This study has been completed.
Information provided by:
Orion Corporation, Orion Pharma Identifier:
First received: October 31, 2005
Last updated: June 22, 2007
Last verified: June 2007
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 Intervention Phase
Parkinson's Disease
Drug: Comtess®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Orion Corporation, Orion Pharma:

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

Estimated Enrollment: 300
Study Start Date: December 2002
Study Completion Date: June 2005

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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)
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Please refer to this study by its identifier: NCT00247247

Orion Pharma GmbH
Hamburg, Germany, 22607 Hamburg
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Günther Deuschl, Professor Klinikum der Christian-Albrechts-Univeristät zu Kiel
  More Information Identifier: NCT00247247     History of Changes
Other Study ID Numbers: 2939089
Study First Received: October 31, 2005
Last Updated: June 22, 2007

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Dopamine Agonists
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors processed this record on April 25, 2017