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Antioxidant Therapy With N-acetylcysteine for Learning and Motor Behavior in Children With Neurofibromatosis Type 1
NCT04481035Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2019
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- Cincinnati Children's Hospital Medical Center
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- neurofibromatosis type 1 (NF1)
01
Overview
Phase 2, randomised, double-blind trial of acetylcysteine in neurofibromatosis type 1 (NF1) (2 arms), sponsored by Cincinnati Children's Hospital Medical Center. Primary endpoints: Physical and Neurological Examination for Subtle Signs at 18 weeks and ADHD Symptoms as Reported Via Parent/Teacher Surveys at 18 weeks. Started Jan 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
N-Acetylcysteine -> Placebo
NAC for 8 weeks, then Placebo for 8 weeks
Placebo -> N-Acetylcysteine
Placebo for 8 weeks, then NAC for 8 weeks
03
Who it enrols
Children aged 8-16 with Neurofibromatosis Type 1, IQ >= 70, without active intracranial lesions, epilepsy, asthma, or major psychiatric disorders.
04
Endpoints
Primary
Physical and Neurological Examination for Subtle Signs
ADHD Symptoms as Reported Via Parent/Teacher Surveys
Secondary
Transcranial Magnetic Stimulation - Cortical Silent Period
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