Gabapentin for Autism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Massachusetts Medical School, Worcester, MAAutism+1 MoreGabapentin - Drug
Eligibility
13 - 17
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Autism

Video Summary

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 8 weeks

8 weeks
Right Anterior Insula GABA level

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Gabapentin
2%Allergic reaction
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03012815) in the Gabapentin ARM group. Side effects include: Allergic reaction with 2%.

Trial Design

1 Treatment Group

Gabapentin Open-label treatment
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Gabapentin · No Placebo Group · Phase 4

Gabapentin Open-label treatment
Drug
Experimental Group · 1 Intervention: Gabapentin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

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

Eligibility Criteria

Age 13 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Autism Spectrum Disorder based on the DSM-5 criteria.

Who else is applying?

What state do they live in?
Ohio25.0%
Montana25.0%
Massachusetts25.0%
Other25.0%
How old are they?
18 - 6566.7%
< 1833.3%
What site did they apply to?
University of Massachusetts Medical School100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria42.9%
Met criteria57.1%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 1 Day
Most responsive sites:
  1. University of Massachusetts Medical School: < 24 hours

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

For what ailments is Gabapentin frequently prescribed?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.