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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00593957
Eligibility Criteria:
Inclusion Criteria:
1. those who have classic or atypical RTT with a proven mutation in the MeCP2 gene;
2. those with documented EEG evidence of spike activity who may or may not have clinical seizures;
3. subjects must be between 2years -14.99 years of age.
Exclusion Criteria:
1. those without an established mutation in the MeCP2 gene;
2. those who do not have EEG evidence of spike activity;
3. those with mutations in the MeCP2 gene but who have had brain resection or surgical intervention; for example, tumor, hydrocephalus, severe head trauma; or, an associated severe medical illnesses such as vasculopathies, malignancies, diabetes, thyroid dysfunction, etc;
4. those on medications that could interact with DM, e.g. monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitor (SSRI), sibutramine etc. to avoid a serotonin syndrome; quinidine and drugs metabolized by the Cytochrome P450 (CYP450) isoform cytochrome P450 2D6 (CYP2D6) (e.g. amiodarone, haloperidol, propafenone, thioridazine);
5. those proven to be intermediate or slow metabolizers of DM;
6. those with reported adverse reactions to DM;
7. those whose pregnancy test is positive; and,
8. those showing poor compliance with any aspect of the study;
9. foster children
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
15 Years
Study:
NCT00593957
Study Brief:
Protocol Section:
NCT00593957