Comtess® Versus Cabaseril® as Add-on to Levodopa in the T... | NCT00247247

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

NCT00247247

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Jun 25, 2007Estimated

Enrollment

300

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

Comtess®

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CAMP

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Jun 2005Actual

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2007

Last Update Posted Date

Jun 25, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
Comtess®	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Günther Deuschl, Professor	Klinikum der Christian-Albrechts-Univeristät zu Kiel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orion Pharma GmbH		Hamburg		22607 Hamburg	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided