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:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT01325220
Eligibility Criteria:
Inclusion Criteria:
* Molecular documentation of the full FMR1 mutation
* Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
* Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
* If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening
Exclusion Criteria:
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who have taken another investigational drug within the last 30 days.
* Subjects who are not able to take oral medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT01325220
Study Brief:
Protocol Section:
NCT01325220