At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
Fenfluramine Hydrochloridedrug
Likely dose
Fenfluramine Hydrochloride 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fenfluramine in CKDL5 Deficiency Disorder (CDD)
In Brief
A Phase 2 clinical trial evaluating Fenfluramine Hydrochloride for CDD. Completed, enrolled 7 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCDD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartOct 2019
Primary CompletionAug 2022
Study CompletionOct 2022
TodayJul 2026
First PostedMar 4, 2019
Enrollment StartOct 29, 2019
Primary CompletionAug 30, 2022
Study CompletionOct 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.3 years ago
Interventions
Fenfluramine Hydrochloridedrug
Oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 2.5 mg/mL. Manufactured by Andersonbrecon, Inc. on behalf of Zogenix International Limited.