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Gabapentin for Autism Spectrum Disorder

Phase < 1
Waitlist Available
Led By David Cochran, MD, PhD
Research Sponsored by University of Massachusetts, Worcester
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 6 hours post-administration
Awards & highlights
No Placebo-Only Group

Summary

This trial tests gabapentin, a medication for nerve pain and seizures, to see if it can help adolescents with Autism Spectrum Disorder (ASD) improve their social communication skills. The study focuses on adolescents aged 13-17 because they often struggle with social communication. Gabapentin may work by increasing a calming brain chemical called GABA. Gabapentin is a newer medication used in children and has been evaluated for its effectiveness and safety in various studies.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours post-administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours post-administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cortical GABA in Anterior Cingulate Cortex
Cortical GABA in Right Anterior Insula
Secondary study objectives
Cortical Glx in Anterior Cingulate Cortex
Cortical Glx in Right Anterior Insula

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GabapentinExperimental Treatment1 Intervention
Single dose of gabapentin 900 mg will be given and neuroimaging markers will be measured before and after administration of gabapentin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,946 Total Patients Enrolled
84 Trials studying Autism Spectrum Disorder
41,233 Patients Enrolled for Autism Spectrum Disorder
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,991 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
6,664 Patients Enrolled for Autism Spectrum Disorder
Johns Hopkins UniversityOTHER
2,326 Previous Clinical Trials
14,874,940 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
239 Patients Enrolled for Autism Spectrum Disorder
~2 spots leftby Nov 2025
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