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NCT03589898 · ClinicalTrials.gov registry record · Early Phase 1
Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of Gabapentin
A Early Phase 1 study of Autism Spectrum Disorder, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03589898: Completed Early Phase 1 study of Autism Spectrum Disorder, sponsored by University of Massachusetts, Worcester.
NCT03589898 is a Early Phase 1 study of Autism Spectrum Disorder that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 19 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03589898, a Early Phase 1 study of Autism Spectrum Disorder, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that is increasing in prevalence, and is characterized by deficits in social communication and interaction across multiple contexts, and restricted, repetitive patterns of behavior, interests, or activities. The majority of individuals with ASD have poor outcomes in the area of social functioning; however, there are no medical treatments available that target the core social communication deficits. The goal of the proposed research is to understand the neurobiological role of an imbalance in excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, GABA) neurotransmission in the social cognition deficits in ASD, and to develop proton magnetic resonance spectroscopy as a measurement of target engagement to measure the ability of a medication, gabapentin, to increase cortical GABA levels. Spectrally-edited proton magnetic resonance spectroscopy (1H-MRS) provides an ideal method for measuring cortical GABA levels. All proposed studies will be in 70 adolescents (male and female) with ASD (age 13 to 17 years). Specific Aim 1: To measure correlations of 1H-MRS GABA levels in the anterior cingulate cortex (ACC) and occipital cortex (OC) with clinical measures of social cognition at baseline. Specific Aim 2: To measure the effect of an initial one time dose of gabapentin on 1H-MRS GABA levels in the ACC and OC. The hypotheses are 1) that higher social cognition ability will be positively correlated with GABA in the ACC but not in the OC (a control, non-social cognition-related region) of individuals with ASD, and 2) that gabapentin will increase GABA levels in the ACC and OC of youth with ASD.
Primary Outcome
Cortical gamma-aminobutyric acid levels measured using magnetic resonance spectroscopy with voxel placed in bilateral anterior cingulate cortex
Conditions Studied
Interventions
- DRUG Gabapentin
Study Locations (1)
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-09-14 |
| Est. Completion | 2022-08-31 |
| Phase | Early Phase 1 |
What the finished NCT03589898 record still lists
NCT03589898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Gabapentin is the first listed.
NCT03589898 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03589898 about?
NCT03589898 is a clinical study titled "Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of Gabapentin". Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that is increasing in prevalence, and is characterized by deficits in social communication and interaction across multiple contexts, and restricted, repetitive patterns of behavior, interests, or activities. The majority of individuals ...
What is the current status of trial NCT03589898?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2017-09-14. Estimated completion is 2022-08-31.
What conditions does trial NCT03589898 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT03589898?
The interventions under investigation include: Gabapentin (DRUG).
Who is sponsoring clinical trial NCT03589898?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03589898 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03589898's enrollment target sits among peer trials
19 203rd of 224 higher than 20 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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