Clinical Trial: Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome

Brief Summary: The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose Acamprosate, lovastatin, minocycline and placebo.

Detailed Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome:

• Change in EEG from baseline [ Time Frame: Pre-dose, 4-hour post-dose ]
  EEG will be used to assess the electrophysiologic aspects of auditory processing
• Clinical Global Impressions Improvement [ Time Frame: 4-hour post-dose ]
  The CGI-I requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical Global Impressions Severity [ Time Frame: Pre-dose ]
  . The CGI-S is a 7-point scale designed to measure global severity of illness over the previous seven days.
• Aberrant Behavior Checklist [ Time Frame: Baseline and beginning of each visit to assess previous 2 weeks ]
  The recently validated Aberrant Behavior Checklist (ABC) using the 6-factor FXS model will be used as a secondary outcome of clinical status.
• Woodcock Johnson Test of cognitive abilities - auditory attention task [ Time Frame: Baseline visit, 4-hour post-dose ]
  Identify parts needed to form a complete shape and Identify orally presented words amid increasingly intense background noise
• Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: Pre-dose, 4-hour post dose ]
  A 10-item list of unrelated words is presented orally to the examinee who is then required to immediately recall words presented.
• Test of Attentional Performance for Children (KiTAP) [ Time Frame: Predose, 4-hour post-dose ]
  Computerized task comprised of 8 subtests where an examinee is required to push a key when a target stimulus is presented on the screen.
• Grooved Pegboard Test [ Time Frame: Baseline visit, 4-hour post-dose ]
  Pegs, with a key along one side, must be rotated to match the holes in the pegboard before they can be inserted.

Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: December 1, 2016
Date Started: January 2016
Date Completion: July 2021
Last Updated: December 15, 2016
Last Verified: December 2016