Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT01956032
Eligibility Criteria:
Inclusion Criteria:
1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
2. Motivated and confident to test Duodopa home titration using TM
3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
4. Understood and signed the study informed consent form
Exclusion Criteria:
1. Dementia or cognitive decline with Mini Mental State Examination score less than 24
2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
3. Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01956032
Study Brief:
Protocol Section:
NCT01956032