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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00376194
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects may be included in the study only if they meet all of the following criteria:
* Male or female subjects, four to ten years of age.
* Meets research criteria for ASD (specifically, autism, Asperger Disorder, or Pervasive Developmental Disorder - Not Otherwise Specified).
* Detectable (greater than 0.1 microgram per deciliter) levels of blood lead and/or blood mercury.
* Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study and must provide written consent to study protocol.
EXCLUSION CRITERIA:
* History of allergic reaction to sulfur or thiol-containing substances
* History of previous chelation therapy for autism
* History of uncontrolled epilepsy
* Weight less than 15 kg at screening
* Presence of a chronic medical condition that might interfere with study participation in which study participation would be contraindicated or in which there may be clinically significant abnormal baseline laboratory results.
* Level of lead above 10 microgram per d, or level of mercury over 44 microgram per deciliter (toxic levels that require intervention with chelation and preclude placebo assignment) or other evidence of heavy metal toxicity.
* Recent (less than two months prior to study entry) initiation of behavior therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT00376194
Study Brief:
Protocol Section:
NCT00376194