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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247247
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : June 25, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Comtess® Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2002
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary objective:
  2. - 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 :
  1. Secondary objectives:
  2. - comparison of the tolerability measured as adverse drug reactions in the course of the study
  3. - comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater
  4. - comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater
  5. - comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters
  6. - comparison of the results of the disease specific questionnaire PDQ-39
  7. - comparison of clinical global evaluation performed by patient
  8. - comparison of ON-time
  9. - comparison of proportion of ON-time
  10. - comparison of daily levodopa doses and total amount of levodopa
  11. - comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247247

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Orion Pharma GmbH
Hamburg, Germany, 22607 Hamburg
Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Principal Investigator: Günther Deuschl, Professor Klinikum der Christian-Albrechts-Univeristät zu Kiel

Layout table for additonal information Identifier: NCT00247247    
Other Study ID Numbers: 2939089
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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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
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Dopamine Agonists