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Completed

NCT Number: NCT00247247

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orion Pharma GmbH

Hamburg, 22607 Hamburg, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comtess®

Drug

Primary outcomes

  1. Primary objective:

  2. - Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy

Secondary outcomes

  1. Secondary objectives:

  2. - comparison of the tolerability measured as adverse drug reactions in the course of the study

  3. - comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater

  4. - comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater

  5. - comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters

  6. - comparison of the results of the disease specific questionnaire PDQ-39

  7. - comparison of clinical global evaluation performed by patient

  8. - comparison of ON-time

  9. - comparison of proportion of ON-time

  10. - comparison of daily levodopa doses and total amount of levodopa

  11. - comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Nov 1, 2005
Registry last updated
Jun 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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