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NCT05367960 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome
A Phase 3 study of Fragile X Syndrome, sponsored by Tetra Discovery Partners.
- Active
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
- 17
- Study locations
NCT05367960: Active Phase 3 study of Fragile X Syndrome, sponsored by Tetra Discovery Partners.
NCT05367960 is a Phase 3 study of Fragile X Syndrome that is active but no longer recruiting, run by Tetra Discovery Partners. The registered enrollment target is 314 participants, above the 82-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (283% higher). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05367960, a Phase 3 study of Fragile X Syndrome, is active but no longer recruiting, sponsored by Tetra Discovery Partners.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
- 17
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 82-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (283% higher). The listed sponsor is Tetra Discovery Partners, which has 8 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 1 intervention - of which Zatolmilast/ BPN14770 is the first listed.
NCT05367960 reports 17 study locations spanning 13 distinct geographic areas - top geographies include California, Massachusetts, Pennsylvania.
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.
What interventions are being tested in trial NCT05367960?
The interventions under investigation include: Zatolmilast/ BPN14770 (DRUG).
Who is sponsoring clinical trial NCT05367960?
This trial is sponsored by Tetra Discovery Partners, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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