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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02448914
• Date of registration: 12/05/2015
• Prospective Registration: No
• Primary sponsor: LobSor Pharmaceuticals AB
• Public title: A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients
• Scientific title: A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease
• Date of first enrolment: May 2015
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02448914
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Dag Nyholm, Assoc. Prof.
• Affiliation: Department of Neuroscience, Neurology, Uppsala University Hospital, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Willing and able to provide informed consent and judged by the Investigator to have
decision-making capacity

2. Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion
since minimum 30 days

3. 30 years of age or older

4. BMI between 17.0 and 31.0 kg/m2, both inclusive

5. 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:

1. Hypersensitivity or allergy to the investigational medicinal product (IMP) or to
chemically related products

2. Contraindications for the use of levodopa or carbidopa or entacapone

3. Needing a daily total dose of Duodopa during study participation exceeding 125 mL

4. Increased fluctuation in clinical PD symptoms within 7 days prior to Screening

5. 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

6. Use of any forbidden medication as specified in Section 9.6 of the protocol

7. Known hepatitis B, hepatitis C or HIV infection

8. Donation of blood or plasma or major blood loss (=500 mL) within 3 months prior to
Screening

9. Positive urine drug test (amphetamine, benzodiazepines, tetrahydrocannabinol, cocaine
or opiates) at Screening

10. Known alcohol abuse

11. Unwilling to meet the requirements of the protocol

12. Other medical or social reasons for exclusion at the discretion of the Investigator



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: TRIGEL

Drug: Duodopa

Primary Outcome(s)

Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa [Time Frame: During 14 h infusion on 2 consecutive days]

Secondary Outcome(s)

Intra-individual Coefficient of Variation (3-14h) for Levodopa [Time Frame: During 3-14h infusion on 2 consecutive days]

Dose Adjusted AUC (0-14h) for Carbidopa [Time Frame: During 14 h infusion on 2 consecutive days]

Dose Adjusted AUC (0-14h) for 3-O-Methyldopa [Time Frame: During 14 h infusion on 2 consecutive days]

Number of Adverse Events [Time Frame: Patients will be followed for the duration of the hospital stay, an expected average of 3 days]

Secondary ID(s)

2014-004891-46

LSM-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

TFS Trial Form Support

Results

• Results available: Yes
• Date Posted: 23/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02448914