NCT01300923

Acamprosate in Youth With Fragile X Syndrome

Pilot Study of Acamprosate in Youth With Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fragile X Syndrome
• Autism Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Acamprosate

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-02-23
• Last updated: 2019-07-30
• Results posted: 2017-04-28

Locations

1 site across 1 country: United States