Study of Acamprosate in Fragile x Syndrome

Completed · Phase 1 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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).

Key facts

Study ID

NCT01911455

Run by

Children's Hospital Medical Center, Cincinnati

People needed

46

Starts

2013-08-27

Expected to finish

2018-11-08

Last updated by the study team

2021-02-03

Who can join

Age: 5 and older, up to 23. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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