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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247247
• Other study ID #: 2939089
• Secondary ID: CAMP
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2005
• Last updated: June 22, 2007
• Start date: December 2002
• Est. completion date: June 2005

Study information

• Verified date: June 2007
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2005
• Gender: Both
• Age group: 60 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Comtess®

Locations

Country	Name	City	State
Germany	Orion Pharma GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary objective:
Primary	- Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
Secondary	Secondary objectives:
Secondary	- comparison of the tolerability measured as adverse drug reactions in the course of the study
Secondary	- comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater
Secondary	- comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater
Secondary	- comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters
Secondary	- comparison of the results of the disease specific questionnaire PDQ-39
Secondary	- comparison of clinical global evaluation performed by patient
Secondary	- comparison of ON-time
Secondary	- comparison of proportion of ON-time
Secondary	- comparison of daily levodopa doses and total amount of levodopa
Secondary	- comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone