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An Initial Study of AZD7325 in Adults With Fragile X Syndrome

NCT03140813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-02-08

No results posted yet for this 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.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

AZD7325 (High-Dose)

15mg PO BID

DRUG

AZD7325 (Low-Dose)

5mg PO BID

DRUG

Placebo oral capsule

Placebo will be dosed similar to AZD7325, in terms of dosage form, frequency and duration.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Ernest Pedapati, MD · Cincinnati Chlidren's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2020-06-18
Completion
2020-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140813 on ClinicalTrials.gov