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Study of Acamprosate in Fragile x Syndrome

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status and phase

Completed
Phase 1

Conditions

Fragile X Syndrome

Treatments

Drug: Placebo
Drug: acamprosate

Study type

Interventional

Funder types

Other

Identifiers

NCT01911455
CIN001- Acamprosate in FX

Details and patient eligibility

About

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).

Full description

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.

Enrollment

46 patients

Sex

All

Ages

5 to 23 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

46 participants in 2 patient groups, including a placebo group

acamprosate
Active Comparator group
Description:
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.
Treatment:
Drug: acamprosate
Placebo
Placebo Comparator group
Description:
Placebo will be prescribed with the same frequency and duration as the acamprosate group.
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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