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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 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 7 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03861871
The ClinicalTrials.gov registry entry for NCT03861871 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fenfluramine Hydrochloride is the first listed.
NCT03861871 reports 0 study locations.
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.
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