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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05163808
The ClinicalTrials.gov registry entry for NCT05163808 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tetra Discovery Partners, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05163808 reports 0 study locations.
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.
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