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COMPLETEDPhase 1NCT01911455

Study of Acamprosate in Fragile x Syndrome

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...

Lead sponsor: Children's Hospital Medical Center, Cincinnati•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Rush University Medical Center

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.

Age

5 - 23 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 3, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment46

Start dateAug 2013

Last updatedFeb 3, 2021

Condition

Fragile X Syndrome

Locations shown

Rush University Medical Center

Chicago, Illinois

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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