Trial record 6 of 42 for:
"Fragile X syndrome"
Acamprosate in Youth With Fragile X Syndrome
This study has been completed.
Sponsor:
Indiana University
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
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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:
Genetics Home Reference related topics:
fragile X syndrome
MECP2 duplication syndrome
PPM-X syndrome
Renpenning syndrome
tetrasomy 18p
U.S. FDA Resources
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
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:
|
Fragile X Syndrome Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Mental Retardation, X-Linked Mental Retardation 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 June 18, 2013