MedTrace Logo

Fenfluramine for Adult Dravet Patients

NCT05560282 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-05

No results posted yet for this study

Summary

Full Title: Fenfluramine for the treatment of refractory Epilepsy in Adult Dravet patients

Short Title: Fenfluramine for Adult Dravet patients

Clinical Phase: Phase III

Sample Size: A total of 15 participants will be included in the study.

Study Population: Adult patients (18 years and older) with drug-resistant epilepsy (maintained on their existing medications, with exception of cannabidiol) and genetically confirmed Dravet syndrome will be recruited to participate in the study.

Accrual Period: 12 months Study Design: Open label, non-randomized and uncontrolled add-on trial in adults (18 years of age and older) residing in Ontario, with refractory motor seizures and maintained on their existing antiepileptic medications, with exception of cannabidiol.

Study Duration:

• Treatment period: 12 months Study duration: 28 months

Study Agent/ Intervention/ Procedure:

Name of study drug: fenfluramine (FINTEPLA)

Dose and frequency: starting at 0.1 mg/kg twice daily, maximum 26 mg/day, in patients not taking concomitant stiripentol; starting at 0.1 mg/kg twice daily, maximum of 17 mg/day in patients taking concomitant stiripentol. All doses are divided to twice a day.

Duration:

Baseline phase: 4 weeks (no study drug) Titration phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol) Treatment phase: 12 weeks Extension phase: up to 38 weeks, for patients who had at least a 50% decrease in seizure frequency Post-trial washout phase: 2 weeks (if not taking stiripentol) to 3 weeks (if the patient is taking stiripentol)

Route of administration:

Oral

Efficacy and safety points of interest

* Monthly convulsive seizure frequency (MCSF) reduction ≥ 50%
* Improvement in motor function
* Improvement in Cognition and Behavior
* Improvement in Quality of Sleep
* Improvement in Quality of life
* Determination of Cardiovascular safety in adults
* Responder analysis (≥25%, ≥75%, or 100% reduction in mean MCSF)
* Longest period of seizure freedom
* Number of Emergency room visits
* Use of rescue medication (number of days in 28 day-periods)
* Duration of post-ictal stage
* Frequency of other seizure types
* Body weight changes
* Patient's global functioning prior to and after study (Clinical Global Impressions Scale)

Trial registration:

www.clinicaltrials.gov

Conditions

Interventions

DRUG

Fenfluramine

FINTEPLA oral solution contains 2.2 mg/mL fenfluramine, equivalent to 2.5 mg/mL of the hydrochloride salt. The active ingredient, fenfluramine hydrochloride, is designated chemically as N-ethyl-α- methyl-3-(trifluoromethyl) phenethylamine hydrochloride. Fenfluramine hydrochloride is a white to off-white crystalline solid. The pKa of fenfluramine is 10.2. FINTEPLA is a clear, colorless solution, pH 5.

Sponsors & Collaborators

  • Zogenix, Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2025-05-13
Completion
2025-05-13
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560282 on ClinicalTrials.gov