Acamprosate in Youth With Fragile X Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fragile X Syndrome Autism Spectrum Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acamprosate

Intervention Type DRUG

Autism Spectrum Disorder

This baseline comparison group will participated in only the psychophysiological and biomarker portion of subject characterization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acamprosate

Intervention Type DRUG

Other Intervention Names

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Campral

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No