A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome

NCT03569631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-19

Study results available
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Summary

This is a single-center, randomized, double-blind, 2-period crossover study to explore the effects of BPN14770 on cognitive function and behavior in subjects with Fragile X Syndrome. Subjects will receive both active treatment with BPN14770 capsules and matching placebo capsules in the course of the study. One treatment will be administered during each of the 12-week study periods.

Conditions

  • Fragile X Syndrome
  • FXS
  • Fra(X) Syndrome

Interventions

DRUG

BPN14770

25 mg BPN14770 capsules

DRUG

Placebo

Placebo capsules to mimic 25 mg BPN14770 capsules

Sponsors & Collaborators

  • Tetra Discovery Partners

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03569631 on ClinicalTrials.gov