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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT01425528
Eligibility Criteria:
Inclusion Criteria:
* established diagnosis of GTPCH deficiency, supported by appropriate family history, CSF neurotransmitter studies, skin fibroblast enzyme assay and/or mutation analysis
* minimum age 18 years
* identified by self or others to have symptoms of anxiety, depression, fatigue, or other neurocognitive dysfunction (trouble concentrating, memory loss, etc)
* willingness to undergo at least 2 CSF evaluations for BH4 and neurotransmitter levels over an 8 to 12 week period
Exclusion Criteria:
* age \< 18 years old
* unwillingness to undergo repeated CSF analysis
* lack of supporting diagnostic criteria
* concomitant medical problems or medications which would increase risk of Kuvan®
* concomitant psychiatric state, such as severe depression with suicidal ideation that requires immediate referral and alternative treatment intervention
* prior history of back surgery, abnormality or chronic pain that in the opinion of the investigator would increase risks associated with lumbar puncture
* significant obesity that might increase difficulty or risk in performing lumbar puncture
* if female, unwillingness to use birth control during the period of study drug administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01425528
Study Brief:
Protocol Section:
NCT01425528