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NCT03479476 · ClinicalTrials.gov registry record · Phase 2
A Trial of Metformin in Individuals With Fragile X Syndrome
A Phase 2 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT03479476: Completed Phase 2 study, sponsored by University of California, Davis.
NCT03479476 is a Phase 2 study that has completed, run by University of California, Davis. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03479476, a Phase 2 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study is a controlled trial of metformin in individuals with fragile X syndrome between the ages of 6 and 25 years. Participants will be randomized in a double-blind design to either drug or placebo and will attend three visits to the study site in a 4-month period for a series of tests. The primary objectives are to assess safety, tolerability, and efficacy of metformin in the treatment of language deficits, behavior problems, and obesity/excessive appetite in individuals with fragile X syndrome.
Primary Outcome
The ELS is collected from shared interactions around a wordless picture book involving the participant and the examiner. The primary outcome measure will be Number of Different Words (NDW) derived from transcripts of audiorecorded samples of spoken language taken from two sampling contexts (conversation and narration), according to procedures described by Abbeduto and colleagues (Abbeduto et al., 1995; Kover et al., 2012). Samples are collected pre- and post- treatment using different books on e
Interventions
- DRUG Metformin
- DRUG Placebo Medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 2 |
What the finished NCT03479476 record still lists
NCT03479476 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT03479476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03479476 about?
NCT03479476 is a clinical study titled "A Trial of Metformin in Individuals With Fragile X Syndrome". This study is a controlled trial of metformin in individuals with fragile X syndrome between the ages of 6 and 25 years. Participants will be randomized in a double-blind design to either drug or placebo and will attend three visits to the study site in a 4-month period for a series of tests. The pr...
What is the current status of trial NCT03479476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-04-30. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT03479476?
The interventions under investigation include: Metformin (DRUG), Placebo Medication (DRUG).
Who is sponsoring clinical trial NCT03479476?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03479476's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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