Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Comtess®

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 60 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Orion Corporation, Orion Pharma
  • Overall Official(s)
    • Günther Deuschl, Professor, Principal Investigator, Klinikum der Christian-Albrechts-Univeristät zu Kiel

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