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Gabapentin for Autism

Phase 4
Recruiting
Led By David Cochran, MD
Research Sponsored by David Cochran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 13-17 years
English as primary language for both child and legal guardian
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will investigate whether gabapentin can correct an imbalance of neurotransmitters in the brain to improve social cognition in adolescents with autism spectrum disorder.

Who is the study for?
This trial is for English-speaking adolescents aged 13-17 with Autism Spectrum Disorder and an IQ over 70. They must be able to give informed assent, with a guardian's consent, and not have genetic disorders like Fragile X or Rett Syndrome. Participants should not have metal implants, severe claustrophobia, unstable psychiatric conditions requiring medication changes during the study, significant medical illnesses, renal dysfunction or be pregnant.Check my eligibility
What is being tested?
The trial tests Gabapentin in adolescents with ASD to see if it can increase GABA levels in the brain and improve social cognition. It involves an initial single dose challenge followed by an 8-week treatment period where effects on GABA levels and social cognition are measured using magnetic resonance spectroscopy (MRS).See study design
What are the potential side effects?
Potential side effects of Gabapentin may include dizziness, sleepiness, water retention leading to swelling in limbs, difficulty walking or controlling muscle movements (ataxia), blurred vision, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 17 years old.
Select...
Both my child and I primarily speak English.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Right Anterior Insula GABA level

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gabapentin Open-label treatmentExperimental Treatment1 Intervention
8-week treatment with 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?

David CochranLead Sponsor
Eagles Autism FoundationUNKNOWN
David Cochran, MDPrincipal InvestigatorUMass Medical School

Media Library

Gabapentin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05063656 — Phase 4
Autism Spectrum Disorder Research Study Groups: Gabapentin Open-label treatment
Autism Spectrum Disorder Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT05063656 — Phase 4
Gabapentin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063656 — Phase 4

Frequently Asked Questions

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

Is the research open for enrollment at present?

"Indeed, the data stored on clinicaltrials.gov states that this clinical trial is still recruiting individuals. It was first listed on February 4th 2022 and has been updated as recently as April 4th 2022 with a goal of admitting 40 patients to be observed at 1 medical site."

Answered by AI

Does using Gabapentin pose any health risks to individuals?

"There is an existing body of evidence attesting to the safety and efficacy of Gabapentin, thus it was awarded a score of 3."

Answered by AI

Do I meet the necessary qualifications to participate in this research?

"This study requires 40 adolescents, aged 13-17 years old and with IQ scores greater than 70 according to the Weschler Abbreviated Scale of Intelligence (WASI), who are also diagnosed with autism spectrum disorder."

Answered by AI

How many participants are included in this experiment?

"Affirmative. Clinicaltrials.gov documents that this experiment, initially posted on February 4th 2022 and most recently revised April 4th 2022, is actively seeking participants. 40 patients from a single site will be required for the trial."

Answered by AI

Has there been any research conducted concerning the efficacy of Gabapentin?

"Currently, there are 25 Gabapentin-centric clinical trials in the works with 9 of them being on Phase 3. Much of this research is centered around Columbus, Ohio; however, 67 other sites have also been enlisted for these studies."

Answered by AI

For what ailments is Gabapentin frequently prescribed?

"Gabapentin can be deployed to mitigate the symptoms of neuralgia, epilepsies, and postherpetic neuralgia."

Answered by AI

Is the age range for this trial inclusive of those aged 35 and up?

"The requirements for inclusion in this trial necessitate that potential participants are between 13 and 17 years old. 231 studies exist which involve minors, while 60 trials cater to people over 65."

Answered by AI

Who else is applying?

What state do they live in?
Montana
Massachusetts
Missouri
Other
How old are they?
< 18
18 - 65
What site did they apply to?
University of Massachusetts Medical School
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Can I be in this trial if I live out of state? If so, will there be any accommodations?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

After research I am hopeful in this trial. No other medications work for me.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of Massachusetts Medical School: < 48 hours
Typically responds via
Email
~13 spots leftby Mar 2025