A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
Sites / Locations
- Clinical Trial Consultants AB
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TRIGEL first, then Duodopa
Duodopa first, then TRIGEL
First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required). All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa. Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump.
First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required). All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa. Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump.