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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
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating children and adolescents with 22q11DS who also have neuropsychiatric conditions.

Eligible Conditions
  • DiGeorge Syndrome

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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.

Find a Location

Who is running the clinical trial?

Nobias Therapeutics, Inc.Lead Sponsor
Neil InalaStudy DirectorNobias Therapeutics, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has NB-001 attained regulatory authorization by the FDA?

"Having considered the data, our analysts at Power have assigned NB-001 a score of 2 on their safety scale. This is because there's evidence supporting its security but none attesting to its efficacy yet."

Answered by AI

Are there currently opportunities for patient involvement in this trial?

"As per clinicaltrials.gov, this medical research is still searching for participants, with the study's initial post date being February 10th 2022 and its last update coming on November 16th of that same year."

Answered by AI

Is there an opportunity to participate in this clinical experiment?

"This trial requires 34 participants with 22q11 deletion syndrome aged between 6 and 17."

Answered by AI

Are there any healthcare facilities in this state currently conducting the trial?

"Eligible patients can enroll in this trial at the renowned Children's Hospital of Philadelphia (CHOP) located in Philadelphia, Pennsylvania, The esteemed Hospital for Sick Kids (SickKids) situated in Toronto, Ontario, Seattle Children's Hospital based in Seattle Washington and an additional 4 sites."

Answered by AI

What is the current enrollment quota for this clinical investigation?

"This clinical trial requires the recruitment of 34 participants who match the parameters detailed in the inclusion criteria. Patients can take part from either Children's Hospital of Philadelphia (CHOP) Pennsylvania, or The Hospital for Sick Children (SickKids) Toronto, Ontario."

Answered by AI

Is eligibility for this research experiment limited to adults?

"According to the trial parameters, children aged 6-17 are eligible for inclusion. In total, 374 studies have been conducted with minors while 983 clinical trials involve participants above 65 years old."

Answered by AI
~12 spots leftby Mar 2025