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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01300923 |
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Date of registration:
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25/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acamprosate in Youth With Fragile X Syndrome
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Scientific title:
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Pilot Study of Acamprosate in Youth With Fragile X Syndrome |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01300923 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig A. Erickson, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine - Department of Psychiatry |
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Key inclusion & exclusion 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.
Age minimum:
5 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Autism Spectrum Disorders
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Intervention(s)
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Drug: Acamprosate
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Primary Outcome(s)
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Clinical Global Impression- Severity Scale (CGI-S)
[Time Frame: Week 10]
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Secondary Outcome(s)
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ADHD Rating Scale 4th Edition
[Time Frame: Week 10]
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Peabody Picture Vocabulary
[Time Frame: Week 10]
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Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain
[Time Frame: Week 10]
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Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD
[Time Frame: Week 10]
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The Aberrant Behavior Checklist (ABC)
[Time Frame: Week 10]
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Brain-derived Neurotrophic Factor (BDNF)
[Time Frame: Screen and Week 10]
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Social Responsiveness Scale
[Time Frame: Week 10]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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