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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.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00247247
First received: October 31, 2005
Last updated: June 22, 2007
Last verified: June 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247247

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

No publications provided

ClinicalTrials.gov Identifier: NCT00247247     History of Changes
Other Study ID Numbers: 2939089, CAMP
Study First Received: October 31, 2005
Last Updated: June 22, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Lithuania: State Medicine Control Agency - Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Entacapone
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014