CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Lovastatin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02642653
NCT02642653Phase 4Completed
CompareCT.gov

Combining Lovastatin and a Parent-Implemented Language Intervention in a Multimodal Treatment for Fragile X Syndrome

University of California, Davis·interventional·Posted Dec 30, 2015·Updated Sep 11, 2019

In Brief

A Phase 4 clinical trial evaluating Lovastatin and Placebo for Fragile X Syndrome and Genetic Diseases. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome, Genetic Diseases
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.5 years ago

Interventions

Lovastatindrug

Once per day dosing

Placeboother

Once per day dosing