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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Comtess®

Primary 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 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

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Orion Corporation, Orion Pharma

Overall Clinical Trial Officials and Contacts

Günther Deuschl, Professor Principal Investigator Klinikum der Christian-Albrechts-Univeristät zu Kiel  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247247

Study ID Number: 2939089

ClinicalTrials.gov Identifier: NCT00247247

Health Authority: Germany: Federal Institute for Drugs and Medical Devices