Acamprosate in Youth With Fragile X Syndrome
Information source: Indiana University
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fragile X Syndrome; Autism Spectrum Disorders
Intervention: Acamprosate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Craig A. Erickson, M.D., Principal Investigator, Affiliation: Indiana University School of Medicine - Department of Psychiatry
Overall contact:
Lauren Mathieu-Frasier, MS, Phone: 317-948-9766, Email: kidpsych@iupui.edu
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.
Clinical Details
Official title: Pilot Study of Acamprosate in Youth With Fragile X Syndrome
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Global Impression-Improvement (CGI-I)
Secondary outcome: The Aberrant Behavior Checklist (ABC)
Eligibility
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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 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.
Locations and Contacts
Lauren Mathieu-Frasier, MS, Phone: 317-948-9766, Email: kidpsych@iupui.edu
Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Craig A. Erickson, M.D., Principal Investigator
Additional Information
Starting date: August 2010
Last updated: February 18, 2011
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