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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT02318966
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study.
* Aged 2 years or older (5 years or older in the USA)
* Established on full intake of uncooked corn starch therapy for at least 6 months
Exclusion Criteria:
* Women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded.
* children less than 2 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
75 Years
Study:
NCT02318966
Study Brief:
Protocol Section:
NCT02318966