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Unknown

AB-2004 for Autism Spectrum Disorder

Phase 2
Waitlist Available
Research Sponsored by Axial 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 from baseline to week 8 visit
Awards & highlights

Study Summary

This trial will test if AB-2004, a new medication, is safe and effective for treating irritability in teens with autism spectrum disorder.

Eligible Conditions
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 8 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 8 visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
Secondary outcome measures
Number of participants who reported treatment emergent adverse events (TEAEs)
Antibodies

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AB-2004Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Axial Therapeutics, Inc.Lead Sponsor

Media Library

AB-2004 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04895215 — Phase 2
Autism Spectrum Disorder Research Study Groups: AB-2004, Placebo
Autism Spectrum Disorder Clinical Trial 2023: AB-2004 Highlights & Side Effects. Trial Name: NCT04895215 — Phase 2
AB-2004 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895215 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned AB-2004 for commercial use?

"Our experts at Power have assigned AB-2004 a rating of 2, since it is in Phase 2 and has some evidence to suggest its safety but none demonstrating efficacy."

Answered by AI

What is the current enrollment numbers for this clinical research endeavor?

"To satisfy the prerequisites of this trial, 195 applicants must take part. The study is accessible at University Hospitals Cleveland Medical Center in Cleveland and CNS Solutions in Orlando, FL."

Answered by AI

Do the selection criteria for this experiment include individuals over fifty years of age?

"Adolescents aged 13 to 17 years old are being sought for this medical research trial."

Answered by AI

Could you provide an overview of the sites that are actively supervising this clinical trial?

"This medical trial is being conducted in 27 cities, including Cleveland, Orlando and New Haven. It is advisable to opt for the closest clinic available when considering participation in order to reduce any necessary travel demands."

Answered by AI

Might I be a suitable candidate for this research study?

"This research is searching for 195 people with autism spectrum disorder aged 13 to 17. To be eligible, applicants must fulfill the following standards: possessing a clinical diagnosis of ASD as per DSM-5 guidelines; ABC-I irritability score above 18 at screening visit and CGI severity scale rating higher than 4 during intake appointment."

Answered by AI

Is enrollment for this experiment still open?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently in the process of participant recruitment; it was first made available on August 2nd 2021 and last edited on August 16th 2022. A total of 195 individuals need to be recruited from 27 different sites across the country."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Massachusetts
Georgia
How old are they?
18 - 65
< 18
What site did they apply to?
University of South Florida
Catherine Masters
Carilion Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

how many visits to Va. will be necessary?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
2021. "AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895215.
~43 spots leftby Apr 2025
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