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NCT03861871 · ClinicalTrials.gov registry record · Phase 2
Fenfluramine in CDKL5 Deficiency Disorder (CDD)
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03861871: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT03861871 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861871, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study will be enrolling 10 patients, ages 2-18 years old, with a confirmed genetic/clinical diagnosis of CDKL5 Deficiency Disorder (CDD) in an open label trial of fenfluramine for seizure control. Patients will be titrated over 14 days to a dose of ZX008 0.8 mg/kg/day (maximum dose 30 mg/d).
Primary Outcome
Change between baseline and Week 14 in the median number of monthly convulsive seizures.
Interventions
- DRUG Fenfluramine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2022-10-24 |
| Phase | Phase 2 |
What the finished NCT03861871 record still lists
NCT03861871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Fenfluramine Hydrochloride is the first listed.
NCT03861871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03861871 about?
NCT03861871 is a clinical study titled "Fenfluramine in CDKL5 Deficiency Disorder (CDD)". This study will be enrolling 10 patients, ages 2-18 years old, with a confirmed genetic/clinical diagnosis of CDKL5 Deficiency Disorder (CDD) in an open label trial of fenfluramine for seizure control. Patients will be titrated over 14 days to a dose of ZX008 0.8 mg/kg/day (maximum dose 30 mg/d).
What is the current status of trial NCT03861871?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-10-29. Estimated completion is 2022-10-24.
What interventions are being tested in trial NCT03861871?
The interventions under investigation include: Fenfluramine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03861871?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861871's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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