Back to resultsComtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Comtess®
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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)
Sites / Locations
- Orion Pharma GmbH
Outcomes
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
Full Information
NCT ID
NCT00247247
First Posted
October 31, 2005
Last Updated
June 22, 2007
Sponsor
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00247247
Brief Title
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Orion Corporation, Orion Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Comtess®
Primary Outcome Measure Information:
Title
Primary objective:
Title
- Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
Secondary Outcome Measure Information:
Title
Secondary objectives:
Title
- comparison of the tolerability measured as adverse drug reactions in the course of the study
Title
- comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater
Title
- comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater
Title
- comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters
Title
- comparison of the results of the disease specific questionnaire PDQ-39
Title
- comparison of clinical global evaluation performed by patient
Title
- comparison of ON-time
Title
- comparison of proportion of ON-time
Title
- comparison of daily levodopa doses and total amount of levodopa
Title
- comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günther Deuschl, Professor
Organizational Affiliation
Klinikum der Christian-Albrechts-Univeristät zu Kiel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orion Pharma GmbH
City
Hamburg
ZIP/Postal Code
22607 Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
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