Clinical trial NCT00247247: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2005-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Primary objective:
measure: - Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
Secondary outcomes:
measure: Secondary objectives:
measure: - comparison of the tolerability measured as adverse drug reactions in the course of the study
measure: - comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater
measure: - comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater
measure: - comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters
measure: - comparison of the results of the disease specific questionnaire PDQ-39
measure: - comparison of clinical global evaluation performed by patient
measure: - comparison of ON-time
measure: - comparison of proportion of ON-time
measure: - comparison of daily levodopa doses and total amount of levodopa
measure: - comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Orion Pharma GmbH
Study officials:
affiliation: Klinikum der Christian-Albrechts-Univeristät zu Kiel
name: Günther Deuschl, Professor
role: PRINCIPAL_INVESTIGATOR
References: