Acamprosate in Youth With Fragile X Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01300923
First received: August 25, 2010
Last updated: January 29, 2013
Last verified: January 2013

August 25, 2010
January 29, 2013
August 2010
September 2011   (final data collection date for primary outcome measure)
Clinical Global Impression-Improvement (CGI-I) [ Time Frame: To be collected at Baseline (Visit 2) and at Week 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01300923 on ClinicalTrials.gov Archive Site
The Aberrant Behavior Checklist (ABC) [ Time Frame: At Screen (Vist 1) Baseline (Visit 2)and Endpoint (Week 10) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acamprosate in Youth With Fragile X Syndrome
Pilot Study of 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fragile X Syndrome
  • Autism Spectrum Disorders
Drug: Acamprosate
Other Name: Camperal
  • 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.
    Intervention: Drug: Acamprosate
  • No Intervention: Autism Spectrum Disorder
    This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characterization.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female outpatients between the ages of 5 and 17 years.
  • Confirmed diagnosis of Fragile X Syndrome based upon genetic testing.
  • Stable dosing of all psychotropic medications for at least 2 weeks prior to baseline.
  • Subjects with a stable seizure disorder or history of only childhood febrile seizures will be included.
  • Clinical Global Impression-Severity Score of 4 (Moderately Ill) or greater.
  • Must be in good physical health.
  • Subjects of child bearing age of both genders will be required to utilize birth control as applicable.

Exclusion Criteria:

  • Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse based on Diagnostic and Statistical Manual Fourth Edition-Text Revised (DSM-IV-TR).
  • A significant medical condition such as heart, liver, renal or pulmonary disease or unstable seizure disorder.
  • Females with a positive urine pregnancy test
  • Creatinine clearance of less than 30.
  • Concomitant use of another glutamatergic agent (memantine,riluzole, d-cycloserine, amantadine topiramate, gabapentin, among others.
  • Evidence of hypersensitivity to acamprosate or potentially serious adverse effect.
  • Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01300923
1003-26
Yes
Indiana University
Indiana University
Not Provided
Principal Investigator: Craig A. Erickson, M.D. Indiana University School of Medicine - Department of Psychiatry
Indiana University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP