Phase 1 Completed N=11 Randomized Treatment

A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients

Source: ClinicalTrials.gov NCT02448914 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcomePrimary: Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa — 40.6; 29.4 h*ng/mL/mg — p=<0.0001

Summary

This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.

Outcome Measures

Outcome	Result	p-value
PRIMARY Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa	40.6; 29.4	<0.0001 sig
SECONDARY Intra-individual Coefficient of Variation (3-14h) for Levodopa	13.8; 10.6	—
SECONDARY Dose Adjusted AUC (0-14h) for Carbidopa	22.1; 18.8	—
SECONDARY Number of Adverse Events	10; 6	—
SECONDARY Dose Adjusted AUC (0-14h) for 3-O-Methyldopa	155; 131	—

Eligibility Criteria

Inclusion Criteria

Willing and able to provide informed consent and judged by the Investigator to have decision-making capacity
Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion since minimum 30 days
30 years of age or older
BMI between 17.0 and 31.0 kg/m2, both inclusive
Agreed to use adequate contraceptive measures:

Female patients who have been post-menopausal for more than one year or female patients of childbearing potential using a highly efficient method of contraception during the study (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner]). Oral contraceptives in combination with other contraceptives are accepted.

Male patients being vasectomised or agreeing to use condoms during the study and having a partner who is using a highly efficient method of contraception as described above.

Exclusion Criteria

Hypersensitivity or allergy to the investigational medicinal product (IMP) or to chemically related products
Contraindications for the use of levodopa or carbidopa or entacapone
Needing a daily total dose of Duodopa during study participation exceeding 125 mL
Increased fluctuation in clinical PD symptoms within 7 days prior to Screening
Administration of an investigational drug within 3 months prior to Screening and/or current participation in another clinical study involving a pharmaceutical or a medical device class III
Use of any forbidden medication as specified in Section 9.6 of the protocol
Known hepatitis B, hepatitis C or HIV infection
Donation of blood or plasma or major blood loss (≥500 mL) within 3 months prior to Screening
Positive urine drug test (amphetamine, benzodiazepines, tetrahydrocannabinol, cocaine or opiates) at Screening
Known alcohol abuse
Unwilling to meet the requirements of the protocol
Other medical or social reasons for exclusion at the discretion of the Investigator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02448914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.