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Benzodiazepine

AZD7325 (High-Dose) for Fragile X Syndrome

Phase 1
Waitlist Available
Led By Ernest Pedapati, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study, approximately 12 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Fragile X Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study, approximately 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study, approximately 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amyloid Precursor Protein (APP)
Secondary outcome measures
Change in the Pediatric Anxiety Rating Scale (PARS)
Change in the Social Withdrawal subscale score of the Aberrant Behavior Checklist (ABC)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Placebo - Low-Dose - High-DoseExperimental Treatment3 Interventions
Placebo AZD7325 5mg BID in gelatin capsules AZD7325 15mg BID in gelatin capsules
Group II: Placebo - High-Dose - Low-DoseExperimental Treatment3 Interventions
Placebo AZD7325 15mg BID in gelatin capsules AZD7325 5mg BID in gelatin capsules
Group III: Low-Dose - Placebo - High-DoseExperimental Treatment3 Interventions
AZD7325 5mg BID in gelatin capsules Placebo AZD7325 15mg BID in gelatin capsules
Group IV: Low-Dose - High-Dose - PlaceboExperimental Treatment3 Interventions
AZD7325 5mg BID in gelatin capsules AZD7325 15mg BID in gelatin capsules Placebo
Group V: High-Dose - Placebo - Low-DoseExperimental Treatment3 Interventions
AZD7325 15mg BID in gelatin capsules Placebo AZD7325 5mg BID in gelatin capsules
Group VI: High-Dose - Low-Dose - PlaceboExperimental Treatment3 Interventions
AZD7325 15mg BID in gelatin capsules AZD7325 5mg BID in gelatin capsules Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD-7325
Not yet FDA approved
AZD-7325
Not yet FDA approved
Placebo oral capsule
2010
Completed Phase 4
~2380

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
816 Previous Clinical Trials
6,575,229 Total Patients Enrolled
6 Trials studying Fragile X Syndrome
480 Patients Enrolled for Fragile X Syndrome
Ernest Pedapati, MDPrincipal InvestigatorCincinnati Chlidren's Hospital
2 Previous Clinical Trials
57 Total Patients Enrolled
~2 spots leftby Jun 2025
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