CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 29 enrolled
Drug / intervention
Acamprosate +4 moredrug
Likely dose
Acamprosate 1332 mg (two 666 mg pills); Lovastatin 40 mg (two 20 mg pills); Minocycline 270 mg (two 135 mg pills); Baclofen 30 mg (one 30 mg pill)AI-extracted
Key inclusion· 4
  • ✓Ages 15-55 with fragile X syndrome (FXS)
  • ✓Full FMR1 mutations (>200 CGG repeats) confirmed by genetic testing
  • ✓Completed prior study: Mechanisms and brain circuits underlying fragile X syndrome (IRB # 2015-8425)
  • ✓General good health per physical exam, medical history, and laboratory work-up
Key exclusion· 9
  • ✕History of intolerance to acamprosate, lovastatin, or minocycline
  • ✕Investigational drug use within 3 months
  • ✕History of substance abuse or dependence within 6 months
  • ✕Significant psychiatric or CNS neurological disease unrelated to FXS

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

Search/NCT02998151
NCT02998151Early Ph 1Completed
CompareCT.gov

Neurophysiological and Acute Pharmacological Studies in FXS Patients

Children's Hospital Medical Center, Cincinnati·interventional·Posted Dec 20, 2016·Updated Nov 26, 2021

In Brief

A Early Phase 1 clinical trial evaluating Acamprosate, Lovastatin, and 3 other interventions for Fragile X Syndrome. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 20, 2016
Enrollment StartJan 1, 2016
Primary CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.5 years ago

Interventions

Acamprosatedrug

two 666mg pills

Lovastatindrug

two 20mg pills

Minocyclinedrug

two 135mg pills

Placebodrug

placebo pill

Baclofendrug

one 30mg pill