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NCT01694667 · ClinicalTrials.gov registry record · Phase 2
Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorders and Hyperactivity, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT01694667 is a Phase 2 study of Autism Spectrum Disorders and Hyperactivity that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 57 participants, below the 165-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01694667, a Phase 2 study of Autism Spectrum Disorders and Hyperactivity, has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo. The overwhelming majority of study procedures, including recruitment, informed consent, assessment of inclusion and exclusion criteria, and collection of baseline and outcome measures will take place over the internet.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Omega-3 Fatty Acids
Study Locations (1)
Maryland
- This study is open to continental USA - Multiple Locations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01694667
The ClinicalTrials.gov registry entry for NCT01694667 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (65% lower). The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01694667 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01694667 about?
NCT01694667 is a clinical study titled "Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder". The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will a...
What is the current status of trial NCT01694667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2012-09. Estimated completion is 2013-05.
What conditions does trial NCT01694667 study?
This clinical trial studies the following conditions: Autism Spectrum Disorders, Hyperactivity.
What interventions are being tested in trial NCT01694667?
The interventions under investigation include: Placebo (OTHER), Omega-3 Fatty Acids (DRUG).
Who is sponsoring clinical trial NCT01694667?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01694667 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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