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NCT02642653 · ClinicalTrials.gov registry record · Phase 4
Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome
A Phase 4 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02642653: Completed Phase 4 study, sponsored by University of California, Davis.
NCT02642653 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02642653, a Phase 4 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of the study is to test the efficacy of a 20 week multi-modal treatment comprised of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children with fragile X syndrome (FXS). Children will be randomized to drug or placebo in a double-blind design with all participating in the PILI. The primary endpoint will be to measure improvements in spoken language and behavior among lovastatin-treated than placebo treated participants.
Primary Outcome
The primary outcome reflects the diversity of vocabulary used. Higher scores reflect more skill. The lowest possible value is zero. No theoretical maximum can be defined because the wordless picture books can lead to a large and indeterminate set of options for the amount of talk and the vocabulary used. In a previous study of a nonpharmacological intervention, the range at baseline was 9-177, and at post-treatment, the range for the combined treated and nontreated groups was 23-214, although th
Interventions
- OTHER Placebo
- DRUG Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-07 |
| Phase | Phase 4 |
What the finished NCT02642653 record still lists
NCT02642653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02642653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02642653 about?
NCT02642653 is a clinical study titled "Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome". The purpose of the study is to test the efficacy of a 20 week multi-modal treatment comprised of lovastatin or placebo, and the Parent-implemented Language Intervention (PILI) in children with fragile X syndrome (FXS). Children will be randomized to drug or placebo in a double-blind design with all ...
What is the current status of trial NCT02642653?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2016-01. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02642653?
The interventions under investigation include: Placebo (OTHER), Lovastatin (DRUG).
Who is sponsoring clinical trial NCT02642653?
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 NCT02642653's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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