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NCT01300923 · ClinicalTrials.gov registry record · Phase 2
Acamprosate in Youth With Fragile X Syndrome
A Phase 2 study of Autism Spectrum Disorders and Fragile X Syndrome, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT01300923 is a Phase 2 study of Autism Spectrum Disorders and Fragile X Syndrome that has completed, run by Indiana University. The registered enrollment target is 14 participants, below the 167-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01300923, a Phase 2 study of Autism Spectrum Disorders and Fragile X Syndrome, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also meet criteria for autistic disorder. The hypothesis of this study is that treatment with acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to assess the potential psychophysiological differences between FXS and autism spectrum disorders.
Conditions Studied
Interventions
- DRUG Acamprosate
Study Locations (1)
Indiana
- Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300923
The ClinicalTrials.gov registry entry for NCT01300923 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (92% lower). The listed sponsor is Indiana University, which has 890 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 1 intervention - of which Acamprosate is the first listed.
NCT01300923 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT01300923 about?
NCT01300923 is a clinical study titled "Acamprosate in Youth With Fragile X Syndrome". Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggress...
What is the current status of trial NCT01300923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2010-08. Estimated completion is 2011-09.
What conditions does trial NCT01300923 study?
This clinical trial studies the following conditions: Autism Spectrum Disorders, Fragile X Syndrome.
What interventions are being tested in trial NCT01300923?
The interventions under investigation include: Acamprosate (DRUG).
Who is sponsoring clinical trial NCT01300923?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01300923 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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