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

This study has been completed.
Sponsor:
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

October 31, 2005
June 22, 2007
December 2002
Not Provided
  • Primary objective:
  • - Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
Same as current
Complete list of historical versions of study NCT00247247 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: Comtess®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
June 2005
Not Provided

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)
Both
60 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00247247
2939089, CAMP
Not Provided
Not Provided
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Günther Deuschl, Professor Klinikum der Christian-Albrechts-Univeristät zu Kiel
Orion Corporation, Orion Pharma
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP