drugset / Trial / NCT02642653
Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lovastatin | Small molecule | 40 mg | Oral |