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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01675960
Eligibility Criteria:
Inclusion Criteria:
* male or female
* 1 month to 16 years of age at enrollment
* neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies
* chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period
* Subject must have an acceptable surrogate capable of giving consent on the subject's behalf
Exclusion Criteria:
* Children with resolved symptoms after treatment of identified sources of pain
* Identified potential source of irritability without adequate trial of appropriate management
* Ketogenic diet
* Renal insufficiency or failure
* Current treatment with gabapentin or pregabalin for another existing condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
16 Years
Study:
NCT01675960
Study Brief:
Protocol Section:
NCT01675960