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NCT03140813 · ClinicalTrials.gov registry record · Phase 1

An Initial Study of AZD7325 in Adults With Fragile X Syndrome

A Phase 1 study of Fragile X Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT03140813 is a Phase 1 study of Fragile X Syndrome that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants, below the 101-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03140813, a Phase 1 study of Fragile X Syndrome, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Placebo oral capsule
  • DRUG AZD7325 (High-Dose)
  • DRUG AZD7325 (Low-Dose)

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2018-01-16
Est. Completion 2020-06-18
Phase Phase 1

What the Registry Record Tells You About NCT03140813

The ClinicalTrials.gov registry entry for NCT03140813 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 101-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (85% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Placebo oral capsule is the first listed.

NCT03140813 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03140813 about?

NCT03140813 is a clinical study titled "An Initial Study of AZD7325 in Adults With Fragile X Syndrome". 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.

What is the current status of trial NCT03140813?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-01-16. Estimated completion is 2020-06-18.

What conditions does trial NCT03140813 study?

This clinical trial studies the following conditions: Fragile X Syndrome.

What interventions are being tested in trial NCT03140813?

The interventions under investigation include: Placebo oral capsule (DRUG), AZD7325 (High-Dose) (DRUG), AZD7325 (Low-Dose) (DRUG).

Who is sponsoring clinical trial NCT03140813?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03140813 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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