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NB-001 in Children and Adolescents With 22q11 Deletion Syndrome
Phase 2
Waitlist Available
Research Sponsored by Nobias Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment; approximately 13 weeks of trial participation
Summary
This trial tests NB-001, a new drug, in children and teenagers with 22q11DS to see if it can improve their mental health symptoms. Researchers hope it will help by changing brain chemicals related to mood and behavior.
Eligible Conditions
- DiGeorge Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment; approximately 13 weeks of trial participation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment; approximately 13 weeks of trial participation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Dictionary v.5.0
Secondary study objectives
Change from baseline in Clinical Global Impression Improvement (CGI-I) Scale
Change from baseline in Clinical Global Impression Severity (CGI-S) Scale
Treatment effect of NB-001 on the Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-5)
+2 moreOther study objectives
Subject experience and meaningfulness of the change(s) while participating in NB-001-01
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: NB-001Active Control1 Intervention
Active drug product, NB-001: Two (2) 100 mg capsules will be administered orally BID with liquids or, if the subject is unable to swallow a capsule whole, capsules may be opened, and the contents sprinkled on applesauce; total daily dose: 400 mg.
Group II: PlaceboPlacebo Group1 Intervention
Placebo: Two (2) capsules (matching NB-001) will be administered orally BID with liquids or, if the subject is unable to swallow a capsule whole, capsules may be opened, and the contents sprinkled on applesauce.
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Who is running the clinical trial?
Nobias Therapeutics, Inc.Lead Sponsor
Neil InalaStudy DirectorNobias Therapeutics, Inc.