Trial record 7 of 44 for:    "Fragile X syndrome"

Study of Acamprosate in Fragile x Syndrome

This study is currently recruiting participants.
Verified March 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborator:
Rush University Medical Center
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01911455
First received: July 26, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Fragile X Syndrome
Drug: acamprosate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Aberrant Behavior Checklist-Social Withdrawal subscale [ Time Frame: Change from baseline to week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impressions- Improvement (CGI-I) [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist- Hyperactivity (ABC-H) [ Time Frame: Change from baseline to week 10 ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist-Social Avoidance (ABC-SA) [ Time Frame: Change from baseline to week 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: acamprosate
Other Name: Campral
Placebo Comparator: Placebo
Placebo will be prescribed with the same frequency and duration as the acamprosate group.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   5 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911455

Contacts
Contact: Katie Friedmann, RN 513-636-0523 fragilex@cchmc.org

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Jamie Chin    312-942-0025    jamie_a_chin@rush.edu   
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    fragilex@cchmc.org   
Principal Investigator: Craig Erickson, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Rush University Medical Center
Investigators
Principal Investigator: Craig Erickson, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Elizabeth Berry-Kravis, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01911455     History of Changes
Other Study ID Numbers: CIN001- Acamprosate in FX
Study First Received: July 26, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Fragile X Syndrome

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014