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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT03591757
Eligibility Criteria:
Inclusion Criteria:
* Genotyping of variant TTR
* Documented CNS manifestation or expression of variant TTR with leptomeningeal potential
Exclusion Criteria:
* Patients who are unable to provide informed consent
* Contraindication for Tolcapone
* An ALT or AST measurement \> 2 times the ULN (Upper Limit of Normal)
* Estimated glomerular filtration rate (eGFR) ≤ 25 ml/min/1.72M2
* Treatment with a known TTR tetramer protein stabilizer within the last 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03591757
Study Brief:
Protocol Section:
NCT03591757