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ACTIVE NOT RECRUITING Phase 3

An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome

NCT05367960 · View on ClinicalTrials.gov ↗

Study Summary

This is a 4-year, open-label extension (OLE) study for subjects completing one of two double-blind clinical trials with BPN14770, Study BPN14770-CNS-301 (in adult males) and Study BPN14770-CNS-204 (in adolescent males).

Conditions Studied

Interventions

  • DRUG Zatolmilast/ BPN14770

Study Locations (17)

California

  • Amnova Clinical Research — Irvine
  • Thompson Autism & Neurodevelopment Center - CHOC — Orange
  • MIND Institute UC Davis Medical Center — Sacramento

Massachusetts

  • Boston Children's Hospital — Boston
  • U Mass — Worcester

Pennsylvania

  • Suburban Research Associates — Media
  • Clinic for Special Children — Strasburg

Colorado

  • Children's Hospital Colorado — Aurora

Florida

  • University of Miami — Miami

Georgia

  • Emory University School of Medicine — Atlanta

Illinois

  • Rush University Medical Center — Chicago

Kansas

  • University of Kansas Medical Center — Kansas City

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2022-11-01
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Tetra Discovery Partners

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05367960

The ClinicalTrials.gov registry entry for NCT05367960 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tetra Discovery Partners, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Zatolmilast/ BPN14770 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05367960 reports 17 study locations spanning 13 distinct geographic areas — top geographies include California, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05367960 about?

NCT05367960 is a clinical study titled "An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome". This is a 4-year, open-label extension (OLE) study for subjects completing one of two double-blind clinical trials with BPN14770, Study BPN14770-CNS-301 (in adult males) and Study BPN14770-CNS-204 (in adolescent males).

What is the current status of trial NCT05367960?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2022-11-01. Estimated completion is 2027-12-31.

What conditions does trial NCT05367960 study?

This clinical trial studies the following conditions: Fragile X Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05367960?

The interventions under investigation include: Zatolmilast/ BPN14770 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05367960?

This trial is sponsored by Tetra Discovery Partners, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05367960 being conducted?

This trial has 17 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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