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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
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In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).
Each subject with FXS will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acamprosate | Active Comparator | The maximum dose of acamprosate to be used in this study is 666 mg three times daily (total 1998 mg/day) for subjects weight ≥ 50 kg and 1332mg for subjects that weigh < 50 kg. |
|
| Placebo | Placebo Comparator | Placebo will be prescribed with the same frequency and duration as the acamprosate group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acamprosate | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist-Social Withdrawal subscale | The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. | Change from baseline to week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions- Improvement (CGI-I) | The CGI-I global improvement item is a 7-point Likert scale designed to measure symptomatic change at a specific time as compared to baseline. CGI-I is a gold standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities. | week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Erickson, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Elizabeth Berry-Kravis, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Cincinnati Children's Hospital Medical Center |
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| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Drug |
|
| Aberrant Behavior Checklist- Hyperactivity (ABC-H) | The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. | Change from baseline to week 10 |
| Aberrant Behavior Checklist-Social Avoidance (ABC-SA) | The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials. | Change from baseline to week 10 |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |