Status:
COMPLETED
Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Neurofibromatosis 1
Eligibility:
All Genders
8-16 years
Phase:
PHASE2
Brief Summary
Children with neurofibromatosis type 1 (NF1) commonly suffer from the effects of cognitive, behavioral, and motor impairments. At present there is no specific treatment for this NF1 complication. Howe...
Detailed Description
The aims of this application are to gain information in children with NF1 about possible clinical benefit of anti-oxidant treatment and to develop and evaluate quantitative brain-based and blood bioma...
Eligibility Criteria
Inclusion
- Males and females aged 8 - 16 years at time of enrollment whom meet NIH diagnostic criteria for NF1.
- Participants must have a full-scale intelligence quotient (IQ) of 70 or above, as determined by neurocognitive testing within the last 3 years or during the enrollment process.
- Participants on stimulant or any other psychotropic medication should stay on a stable dose for at least 30 days before entering the study.
Exclusion
- Participants should not be receiving chemotherapy currently, or have received chemotherapy in the 6 months prior to entering the study.
- No active intracranial lesions (stable low grade glioma are acceptable) or epilepsy diagnosis.
- Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other major Anxiety Disorders, or other developmental psychiatric diagnoses, based on the child's history or on parent and child responses from the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS). Note that while this is an exclusion for participation in the study if there is a prior evaluation available, this becomes a criterion, after inclusion, for the investigator to withdraw the child from the study prior to completion if identified on the first study day.
- For females, pregnancy.
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
- Implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal (VP) shunt, cardiac pacemaker, or implanted medication port.
- Asthma (bronchospasm has been reported as occurring infrequently and unpredictable when acetylcysteine is used as a mucolytica agent).
- High risk of upper gastrointestinal (GI) hemorrhage. Examples: presence of esophageal varices or peptic ulcers
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04481035
Start Date
January 15 2019
End Date
December 16 2021
Last Update
July 31 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229