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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00001359
Eligibility Criteria:
INCLUSION CRITERIA:
1. Ages 4 - 18 years
2. Fulfill criteria for membership in the PANDAS subgroup:
1. Presence of OCD and/or tic disorder
2. Prepubertal symptom onset
3. Abrupt onset and episodic (relapsing-remitting) symptom course
4. Association between symptom exacerbations and GABHS infections
5. Presence of choreiform movements or other neurological abnormalities during symptom exacerbations.
Because "time to relapse" is one of the primary outcome variables, children will not be eligible for randomization until their symptoms are in (at least partial) remission. At the time of randomization, symptom severity scores should be less than 50% of the child's previous maximum score on both the CY-BOCS and YGTSS, and no higher than a total score of 20 on the CY-BOCS or 30 on the YGTSS.
EXCLUSION CRITERIA:
1. Personal history of penicillin allergy
2. History of rheumatic fever, including Sydenham's chorea
3. Diagnosis of autism, schizophrenia or other psychotic disorder
4. Chronic illnesses, particularly neurologic and immunologic disorders
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001359
Study Brief:
Protocol Section:
NCT00001359