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NCT05630066 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Pharmacokinetics (PK) and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT05630066: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT05630066 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630066, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion AS aged 5-17 years (inclusive) will be enrolled in the study.
Primary Outcome
Age-group based ratio of plasma PK parameters in pediatric participants with AS versus data collected from adult healthy volunteers and participants with autism spectrum disorder (ASD) (AUC)
Interventions
- DRUG Alogabat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-07-27 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 2 |
What the finished NCT05630066 record still lists
NCT05630066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Alogabat is the first listed.
NCT05630066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05630066 about?
NCT05630066 is a clinical study titled "A Study to Investigate the Pharmacokinetics (PK) and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype.". This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion AS aged 5-17 years (inclusive) will be enrolled in the study.
What is the current status of trial NCT05630066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-07-27. Estimated completion is 2025-12-02.
What interventions are being tested in trial NCT05630066?
The interventions under investigation include: Alogabat (DRUG).
Who is sponsoring clinical trial NCT05630066?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05630066's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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