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NCT03569631 · ClinicalTrials.gov registry record · Phase 2
A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome
A Phase 2 study, sponsored by Tetra Discovery Partners.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03569631: Completed Phase 2 study, sponsored by Tetra Discovery Partners.
NCT03569631 is a Phase 2 study that has completed, run by Tetra Discovery Partners. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03569631, a Phase 2 study, has completed, sponsored by Tetra Discovery Partners.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
A TEAE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A Serious Adverse Event (SAE) was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defec
Interventions
- DRUG Placebo
- DRUG BPN14770
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 2 |
What the finished NCT03569631 record still lists
NCT03569631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03569631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03569631 about?
NCT03569631 is a clinical study titled "A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome". 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...
What is the current status of trial NCT03569631?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-07-09. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03569631?
The interventions under investigation include: Placebo (DRUG), BPN14770 (DRUG).
Who is sponsoring clinical trial NCT03569631?
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 NCT03569631's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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