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NCT05149898 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE)
A Phase 2 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT05149898: Completed Phase 2 study, sponsored by Harmony Biosciences Management.
NCT05149898 is a Phase 2 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05149898, a Phase 2 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel formulation, for up to 38 weeks, in participants ages 4 to \<18 years, in the treatment of 22q.11.2 Deletion syndrome (22qDS).
Primary Outcome
An adverse event (AE) is an undesirable medical occurrence or worsening of a pre-existing medical condition that occurs at any time after signing of the informed consent form whether or not it is considered to be related to treatment. Any AE that results in one or more of the following is considered a SAE: death, life threatening, in-patient hospitalization, persistent or significant disability/incapacity, congenital abnormality or birth defect, and other medically important events. TEAEs are de
Interventions
- DRUG ZYN002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-02-19 |
| Est. Completion | 2022-11-09 |
| Phase | Phase 2 |
What the finished NCT05149898 record still lists
NCT05149898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which ZYN002 is the first listed.
NCT05149898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05149898 about?
NCT05149898 is a clinical study titled "Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE)". To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel formulation, for up to 38 weeks, in participants ages 4 to \<18 years, in the treatment of 22q.11.2 Deletion syndrome (22qDS).
What is the current status of trial NCT05149898?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-02-19. Estimated completion is 2022-11-09.
What interventions are being tested in trial NCT05149898?
The interventions under investigation include: ZYN002 (DRUG).
Who is sponsoring clinical trial NCT05149898?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05149898's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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