drugset / Trial / NCT02642653

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

NCT02642653

Phase 4 Completed 30 enrolled University of California, Davis
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-01
Primary completion
2018-07
Completion
2018-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lovastatin Small molecule 40 mg Oral

Indications