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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).
Primary Outcome
Long-term safety and tolerability of BPN14770 in these subjects with fragile X syndrome (FXS) who were treated in one of those parent clinical trials. Safety/tolerability endpoint: Treatment Emergent Adverse Events (TEAEs), which will be coded using the Medical Dictionary for Regulatory Activities. Subject incidence of each system organ class and unique preferred term will be tabulated, including all TEAEs, at least possibly related TEAEs, TEAEs resulting discontinuation of study treatment, TEAE
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 |
What the registry record for NCT05367960 still lists
NCT05367960 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (283% higher).
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 lists 17 locations in 13 states (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.
Learn More About Clinical Trials
Similar trials for Fragile X Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05367960's enrollment target sits among peer trials
314 2nd of 16 the highest of 16 other Fragile X Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fragile X Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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