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Gabapentin for Autism
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 88 Patients • NCT03012815Trial Design
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Who is running the clinical trial?
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- I am taking medications that can slow my breathing.I have a genetic disorder like Fragile X or Rett Syndrome.You meet the specific criteria outlined in the DSM-5 for Autism Spectrum Disorder.I do not have uncontrolled diabetes, asthma, or thyroid disease.I have had kidney problems in the past.I am between 13 and 17 years old.Both my child and I primarily speak English.I have a neurological disorder.I expect to change my psychiatric medication during the study.I am currently taking gabapentin.I am between 13 and 17 years old.You have been diagnosed with Autism Spectrum Disorder according to the DSM-5 criteria.You must give informed consent.You are sexually active and agree to use two forms of contraception during trial to avoid pregnancy.
- Group 1: Gabapentin Open-label treatment
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
For what ailments is Gabapentin frequently prescribed?
"Gabapentin can be deployed to mitigate the symptoms of neuralgia, epilepsies, and postherpetic neuralgia."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- University of Massachusetts Medical School: < 48 hours
Typically responds via
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