|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 February 2021 |
|
Main ID: |
NCT01911455 |
|
Date of registration:
|
26/07/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of Acamprosate in Fragile x Syndrome
|
|
Scientific title:
|
Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome |
|
Date of first enrolment:
|
August 27, 2013 |
|
Target sample size:
|
46 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01911455 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Craig Erickson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Children's Hospital Medical Center, Cincinnati |
|
|
Name:
|
Elizabeth Berry-Kravis, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rush University Medical Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnostic confirmation of full mutation FXS
- Age =5 years and <23 years
- General good health as determined by physical exam, medical history and laboratory
work up.
Exclusion Criteria:
- Use of more than two psychotropic medications (medications affecting behavior).
- Unstable dosing of any psychotropic medication (medication affecting behavior)
- Problems with kidney functioning
- Unstable seizure disorder
- Change in any anti-convulsant drug dosing in the 60 days prior to study entry
- Prior adequate treatment trial with acamprosate as determined by the study doctor
- Pregnant or lactating females
Age minimum:
5 Years
Age maximum:
23 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Fragile X Syndrome
|
|
Intervention(s)
|
|
Drug: acamprosate
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Aberrant Behavior Checklist-Social Withdrawal subscale
[Time Frame: Change from baseline to week 10]
|
|
Secondary Outcome(s)
|
|
Aberrant Behavior Checklist-Social Avoidance (ABC-SA)
[Time Frame: Change from baseline to week 10]
|
|
Clinical Global Impressions- Improvement (CGI-I)
[Time Frame: week 10]
|
|
Aberrant Behavior Checklist- Hyperactivity (ABC-H)
[Time Frame: Change from baseline to week 10]
|
|
Secondary ID(s)
|
|
CIN001- Acamprosate in FX
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|