drugset / Trial / NCT01300923

Acamprosate in Youth With Fragile X Syndrome

NCT01300923

Phase 2 Completed 14 enrolled Indiana University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also meet criteria for autistic disorder. The hypothesis of this study is that treatment with acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to assess the potential psychophysiological differences between FXS and autism spectrum disorders.

Timeline

Start
2010-08
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acamprosate Small molecule 1332 mg
Comparator Acamprosate Small molecule 1998 mg