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NCT05163808 · ClinicalTrials.gov registry record · Phase 2
A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome
A Phase 2 study, sponsored by Tetra Discovery Partners.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT05163808: Completed Phase 2 study, sponsored by Tetra Discovery Partners.
NCT05163808 is a Phase 2 study that has completed, run by Tetra Discovery Partners. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05163808, a Phase 2 study, has completed, sponsored by Tetra Discovery Partners.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
This is a 2-part study, with each part having a unique set of objectives for male adolescents aged 9 to \< 18 years with fragile X syndrome (FXS). Part 1 is an open-label, single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and 50 mg, while Part 2 is double-blind (DB) and randomized between two treatment groups (Study Drug and Placebo).
Primary Outcome
The change from baseline to Week 13 in the NIH Toolbox Cognitive Battery cognition crystallized composite score (NIH-TCB CCC), which is calculated from the Picture Vocabulary and Oral Reading domains.
Interventions
- DRUG Placebo
- DRUG zatolmilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2025-09-02 |
| Phase | Phase 2 |
What the finished NCT05163808 record still lists
NCT05163808 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05163808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05163808 about?
NCT05163808 is a clinical study titled "A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome". This is a 2-part study, with each part having a unique set of objectives for male adolescents aged 9 to \< 18 years with fragile X syndrome (FXS). Part 1 is an open-label, single-dose, pharmacokinetics (PK) assessment of BPN14770 25 mg and 50 mg, while Part 2 is double-blind (DB) and randomized betw...
What is the current status of trial NCT05163808?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2022-03-29. Estimated completion is 2025-09-02.
What interventions are being tested in trial NCT05163808?
The interventions under investigation include: Placebo (DRUG), zatolmilast (DRUG).
Who is sponsoring clinical trial NCT05163808?
This trial is sponsored by Tetra Discovery Partners, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05163808's enrollment target sits among peer trials
163 418th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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