Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003581-26-SE

Enrollment

Registered

2008-05-30

Start date

2008-07-18

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment. MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's

Interventions

Trade Name: Duodopa Pharmaceutical Form: Gel INN or Proposed INN: levodopa CAS Number: 59-92-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinically diagnosed Parkinson's disease, ongoing Duodopa therapy. Age 30-90 years. At least 4 persons of each gender. Hoehn & Yahr-stage 3-5 at worst. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Ongoing treatment with COMT-inhibitor. Dementia. Psychosis. Treatment with neuroleptics (atypical neuroleptics are OK). Liver disease. Hypersensitivity against Comtess or Tasmar.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study difference in coefficient of variation in plasma levodopa concentration between Duodopa treatment alone and in combination with Comtess or Tasmar. ;Secondary Objective: Other pharmacokinetic variables. Differences in patient-perceived motor function and motor function as assessed by blinded raters.;Primary end point(s): Change in daily coefficient of variation of plasma levodopa between baseline and the days with entacapone and tolkapon as additional treatment.	—

Measure

Time frame

Main Objective: To study difference in coefficient of variation in plasma levodopa concentration between Duodopa treatment alone and in combination with Comtess or Tasmar. ;Secondary Objective: Other pharmacokinetic variables. Differences in patient-perceived motor function and motor function as assessed by blinded raters.;Primary end point(s): Change in daily coefficient of variation of plasma levodopa between baseline and the days with entacapone and tolkapon as additional treatment.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026