Parkinson DiseasePhase 4DuoCOMTNCT00906828
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
A Phase 4 study testing levodopa/carbidopa, entacapone and tolcapone in people with Parkinson Disease, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- levodopa/carbidopa, entacapone and tolcapone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Nov 2009
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Duodopa treatment ongoing
- Hoehn \& Yahr stage 3-5 at worst
Who cannot join
- Ongoing treatment with COMT inhibitors
- Dementia
- Psychosis
- Treatment with typical neuroleptics
- Contraindications for entacapone or tolcapone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.
Read the detailed description
The aim is to measure variability in plasma levodopa levels during the following three treatments:
Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.
- Conditions
- Parkinson Disease
- Being tested
- levodopa/carbidopa, entacapone, tolcapone
- Keywords
- Levodopa/carbidopa infusion, entacapone, tolcapone, efficacy, pharmacokinetic, pharmacodynamics
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa/carbidopaDrug
Also called Duodopa
intestinal gel, continuous infusion (daytime or 24-hour)
entacaponeDrug
Also called Comtess, Comtan.
Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
tolcaponeDrug
Also called Tasmar
Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
| Study group | Role | What they receive |
|---|---|---|
| 1. Duodopa, optimised dose | Active comparator | Not described Receives: Drug: levodopa/carbidopa |
| 2. 80% Duodopa + entacapone | Experimental | 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Receives: Drug: entacapone |
| 3. 80% Duodopa + tolcapone | Experimental | 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Receives: Drug: tolcapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
Measured: 3 days
Secondary outcomes (1)
Difference in Treatment Response Scale between the treatments.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
- Investigators
- Dag Nyholm, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906828
- Sponsor's protocol ID
- DuoCOMT
- Acronym
- DuoCOMT
- Status last verified
- Jan 2010
- First submitted
- 19 May 2009
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyholm D. Enteral levodopa/carbidopa gel infusion for the treatment of motor fluctuations and dyskinesias in advanced Parkinson's disease. Expert Rev Neurother. 2006 Oct;6(10):1403-11. doi: 10.1586/14737175.6.10.1403.
PubMed 17078781
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
- ClinicalTrials.gov ID
- NCT00906828
- Acronym / sponsor ID
- DuoCOMT / DuoCOMT
- Conditions
- Parkinson Disease
- Keywords
- Levodopa/carbidopa infusion, entacapone, tolcapone, efficacy, pharmacokinetic, pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 May 2009 (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.
The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.
Detailed description
The aim is to measure variability in plasma levodopa levels during the following three treatments:
Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Duodopa, optimised dose | Active comparator | Drug: levodopa/carbidopa |
| 2. 80% Duodopa + entacapone | Experimental | Drug: entacapone80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours |
| 3. 80% Duodopa + tolcapone | Experimental | Drug: tolcapone80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease
- Duodopa treatment ongoing
- Hoehn \& Yahr stage 3-5 at worst
Key exclusion criteria (5 listed)
- Ongoing treatment with COMT inhibitors
- Dementia
- Psychosis
- Treatment with typical neuroleptics
- Contraindications for entacapone or tolcapone
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 |
|---|---|---|
| levodopa/carbidopaAlso: Duodopaintestinal gel, continuous infusion (daytime or 24-hour) | Drug | 1. Duodopa, optimised dose |
| entacaponeAlso: Comtess, Comtan.Tablet, 200 mg, given twice during the study at t=0h and t=5hrs | Drug | 2. 80% Duodopa + entacapone |
| tolcaponeAlso: TasmarTablet, 100 mg, given twice during study, at t=0h and t=5hrs. | Drug | 3. 80% Duodopa + tolcapone |
Primary outcome
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
Time frame: 3 days
1 secondary outcome
Difference in Treatment Response Scale between the treatments.
Time frame: 3 days
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 18 Jan 2010.
- Background: PubMed 17078781Nyholm D. Enteral levodopa/carbidopa gel infusion for the treatment of motor fluctuations and dyskinesias in advanced Parkinson's disease. Expert Rev Neurother. 2006 Oct;6(10):1403-11. doi: 10.1586/14737175.6.10.1403.
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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.
Dag Nyholm, MD, PhD principal investigator
Uppsala University
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 levodopa/carbidopa, entacapone and tolcapone in people with Parkinson Disease, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 5 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 18 Jan 2010. 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 Sweden. 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?
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906828, which also lists 1 linked publication.
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 18 Jan 2010.