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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 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 30 participants.
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.
Interventions
- OTHER Placebo
- DRUG Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02642653
The ClinicalTrials.gov registry entry for NCT02642653 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02642653 reports 0 study locations.
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.
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