AB-2004 for Autism Spectrum Disorder

Recruiting at 42 trial locations

Overseen By Clinical Trial Team

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Axial Therapeutics, Inc.

Must not be taking: Antibiotics, Antipsychotics

Disqualifiers: Schizophrenia, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

156 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing AB-2004 to see if it can safely and effectively reduce irritability in people with autism spectrum disorder by changing their gut bacteria.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like antibiotics or antipsychotics, before joining the trial. The trial does not allow the use of oral controlled or extended-release medications.

How is the drug AB-2004 for autism spectrum disorder different from other treatments?

AB-2004 is unique because it specifically targets the gut-brain axis, which is a novel approach compared to other treatments for autism spectrum disorder that often focus on behavioral symptoms or neurotransmitter systems. This drug aims to reduce certain gut-derived metabolites that may influence brain function and behavior in individuals with autism. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

Your condition is considered to be severe by the doctor conducting the screening.

Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria)

Aberrant Behavior Checklist - Irritability (ABC-I) score ≥18 at the screening visit

Exclusion Criteria

Use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted

Current use of an oral controlled or extended-release medication

Have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the subject's ability to complete study procedures/comply with study requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AB-2004 or placebo to assess efficacy, safety, and tolerability

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AB-2004
• Placebo

Participant Groups

Group I: AB-2004 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Axial Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

160+

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of placebo response in pharmacological and dietary supplement treatment trials in pediatric autism spectrum disorder: a meta-analysis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Placebo response in pharmacological and dietary supplement trials of autism spectrum disorder (ASD): systematic review and meta-regression analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Placebo-like response in absence of treatment in children with Autism. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Placebo effects in children with autism spectrum disorder. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Therapies for Autism Spectrum Disorder. [2020]