Safety and Efficacy of NB-001 in 22q11DS Children with Anxiety, Inattention, and/or Autism

Safety and Efficacy of NB-001 in 22q11DS Children with Anxiety, Inattention, and/or Autism

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This study is no longer recruiting.

Description

The aim of this study is to determine ifNB-001 (an investigational drug that is not approved by the FDA) is effective, safe, and well tolerated intreating children and adolescents with 22q11DS and anxiety, inattention, and/or autism. The study will take place over a 21-week period with routine telemedicine check-ins, home health nurse visits, and behavioral questionnaires. Except for the first visit which will be in-person at the CHOP Philadelphia campus, all other study visits will be done at the patient's home by a study nurse.

Eligibility and criteria
IRB Number:
21-018574
Eligible age range:
6 years - 17 years
Clinical trial phase:
Phase II
Official title:
Safety and Efficacy of NB-001 in Children with 22q11.2 Deletion Syndrome and Associated ADHD- Anxiety, and Autism Spectrum Disorder

What to expect

Visits will involve:

  • Physical examinations, Bloodwork (screening visit will require fasting and optional genetic testing), ECG, Urine tests
  • Telemedicine call with the study doctor
  • Behavioral questionnaires and interviews with a psychologist

Related specialties
Smiling CHOP patient holding shopping bag

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