Acamprosate in Youth With Fragile X Syndrome
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Acamprosate in Youth With Fragile X Syndrome|
- Clinical Global Impression-Improvement (CGI-I) [ Time Frame: To be collected at Baseline (Visit 2) and at Week 10 ] [ Designated as safety issue: No ]
- The Aberrant Behavior Checklist (ABC) [ Time Frame: At Screen (Vist 1) Baseline (Visit 2)and Endpoint (Week 10) ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Acamprosate
The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
Other Name: Camperal
No Intervention: Autism Spectrum Disorder
This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characterization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300923
|United States, Indiana|
|Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Craig A. Erickson, M.D.||Indiana University School of Medicine - Department of Psychiatry|