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
  Purpose

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.


Condition Intervention Phase
Fragile X Syndrome
Autism Spectrum Disorders
Drug: Acamprosate
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: To be collected at Baseline (Visit 2) and at Week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Aberrant Behavior Checklist (ABC) [ Time Frame: At Screen (Vist 1) Baseline (Visit 2)and Endpoint (Week 10) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Acamprosate
Other Name: Camperal
No Intervention: Autism Spectrum Disorder
This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characterization.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300923

Locations
United States, Indiana
Riley Child and Adolescent Psychiatry Clinic - Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Craig A. Erickson, M.D. Indiana University School of Medicine - Department of Psychiatry
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01300923     History of Changes
Other Study ID Numbers: 1003-26
Study First Received: August 25, 2010
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Fragile X Syndrome
Acamprosate

Additional relevant MeSH terms:
Autistic Disorder
Fragile X Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014