Study of Acamprosate in Fragile x Syndrome
|ClinicalTrials.gov Identifier: NCT01911455|
Recruitment Status : Recruiting
First Posted : July 30, 2013
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fragile X Syndrome||Drug: acamprosate Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 :||February 2018|
|Estimated Study Completion Date :||February 2018|
U.S. FDA Resources
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911455
|Contact: Katie Friedmann, RNfirstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Jamie Chin 312-942-0025 email@example.com|
|Principal Investigator: Elizabeth Berry-Kravis, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Katie Friedmann, RN 513-636-0523 firstname.lastname@example.org|
|Principal Investigator: Craig Erickson, MD|
|Principal Investigator:||Craig Erickson, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Elizabeth Berry-Kravis, MD||Rush University Medical Center|