Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1

PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

January 15, 2019

Primary Completion Date

June 14, 2020

Study Completion Date

December 16, 2021

Conditions
Neurofibromatosis 1
Interventions
DRUG

N-acetylcysteine (NAC)

The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the experimental phase/arm will receive 70 mg/kg/dose (max dose 900 mg) three times per day of NAC for eight (8) weeks.

OTHER

Placebo

The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the placebo phase/arm will receive placebo (non-drug) three times per day for eight (8) weeks.

Trial Locations (1)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT04481035 - Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1 | Biotech Hunter | Biotech Hunter