Parkinson's DiseasePhase 4NCT00247247
Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.
A Phase 4 study testing Comtess® in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Comtess®
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2002to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- known hypersensitivity to ergot derivatives and entacapone
- dementia (MMSE <= 24)
- depression (Beck Scale >= 17)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- Comtess®
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comtess®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (11)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startDec 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Günther Deuschl, Professor, Principal investigator, Klinikum der Christian-Albrechts-Univeristät zu Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247247
- Sponsor's protocol ID
- 2939089
- Other IDs
- CAMP
- Status last verified
- Jun 2007
- First submitted
- 31 Oct 2005
- Last updated
- 25 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00247247
- Acronym / sponsor ID
- 2939089
- Conditions
- Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Jun 2005 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comtess® | Drug | – |
Primary outcome
Primary objective:
- Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Günther Deuschl, Professor principal investigator
Klinikum der Christian-Albrechts-Univeristät zu Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comtess® in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2007.