Study of Acamprosate in Fragile x Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01911455|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2013
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: acamprosate Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: acamprosate
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.
Other Name: Campral
Placebo Comparator: Placebo
Placebo will be prescribed with the same frequency and duration as the acamprosate group.
- Aberrant Behavior Checklist-Social Withdrawal subscale [ Time Frame: Change from baseline to week 10 ]The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.
- Clinical Global Impressions- Improvement (CGI-I) [ Time Frame: week 10 ]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.
- Aberrant Behavior Checklist- Hyperactivity (ABC-H) [ Time Frame: Change from baseline to week 10 ]The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.
- Aberrant Behavior Checklist-Social Avoidance (ABC-SA) [ Time Frame: Change from baseline to week 10 ]The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911455
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Craig Erickson, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Elizabeth Berry-Kravis, MD||Rush University Medical Center|