Trial intelligence / Profile preview

Lovastatin and PILI in Fragile X Syndrome

NCT02642653Phase 4

Key facts

Status: Completed
Start: Jan 2016
Primary completion: Jul 2018
Countries: 1
Sponsor: University of California, Davis
Modality: Small Molecules

Drugs: lovastatin
Conditions: Fragile X syndrome (FXS)

Overview

Phase 4, randomised, double-blind trial in Fragile X syndrome (FXS) comparing Lovastatin + PILI with Placebo + PILI (2 arms). Primary endpoint: Expressive Language Sample Composite Score in the Home at 20 weeks. Started Jan 2016; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Lovastatin + PILI
Lovastatin daily + Parent-Implemented Language Intervention
Placebo + PILI
Placebo daily + Parent-Implemented Language Intervention

Who it enrols

Children aged 10-17 with Fragile X Syndrome (full mutation with FMRP deficiency), IQ <= 70, and using speech as primary communication.

Endpoints

Primary

Expressive Language Sample Composite Score in the Home20 weeks

Secondary

FXS-Normed Aberrant Behavior Checklist (ABC) Social Avoidance Subscale20 weeks
Clinical Global Impression-Severity
Clinical Global Impression-Improvement20 weeks
Visual Analog Scale (VAS) - Spoken Language Impairment20 weeks
Visual Analog Scale (VAS) - Social Impairment20 weeks

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