Clinical Trial: An Initial Study of AZD7325 in Adults With Fragile X Syndrome
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: An Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X Syndrome
Brief Summary: This study will investigate the safety, tolerability and blood pharmacodynamics of treatment with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers during treatment.
Detailed Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Amyloid Precursor Protein (APP) [ Time Frame: Through end of study, approximately 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in the Social Withdrawal subscale score of the Aberrant Behavior Checklist (ABC) [ Time Frame: Through end of study, approximately 12 weeks ]The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.
- Change in the Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Through end of study, approximately 12 weeks ]The PARS is the gold standard parent/caregiver reported anxiety outcome measure for use in Fragile X Syndrome clinical trials.
Original Secondary Outcome: Same as current
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: April 17, 2017
Date Started: May 2017
Date Completion: July 2018
Last Updated: May 2, 2017
Last Verified: May 2017