Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
This study has been completed.
Sponsor:
Orion Corporation, Orion Pharma
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
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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
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 Stress, Psychological Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Behavioral Symptoms Levodopa Cabergoline Entacapone |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antineoplastic Agents Dopamine Agonists Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013