NB-001 for DiGeorge 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment; approximately 13 weeks of trial participation for reporting.

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 more

Other 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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