An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515680-61-00

Acronym

ZX008-1900(EP0215)

Enrollment

104

Registered

2024-09-16

Start date

2020-02-07

Completion date

2025-05-08

Last updated

2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dravet syndrome or Lennox-Gastaut syndrome

Brief summary

The safety endpoints of the study are: • AEs • Laboratory safety (hematology, chemistry) • Vital signs (blood pressure, heart rate, temperature, and respiratory rate) • Physical examination • Neurological examination • Electrocardiogram (ECGs) • Doppler echocardiogram (ECHOs) • Body weight/height • Chest x-ray (subjects in France and Netherlands only) • Electroencephalogram (EEG) (in Italy only)

Detailed description

The effectiveness endpoints of the study are: • CGI-I, global and symptomatic, as assessed by parent/caregiver • CGI-I, global and symptomatic, as assessed by investigator (or designee) • Percent improvement in seizure burden as assessed by the investigator (or designee)

Interventions

DRUGFintepla 2.2 mg/ml oral solution

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The safety endpoints of the study are: • AEs • Laboratory safety (hematology, chemistry) • Vital signs (blood pressure, heart rate, temperature, and respiratory rate) • Physical examination • Neurological examination • Electrocardiogram (ECGs) • Doppler echocardiogram (ECHOs) • Body weight/height • Chest x-ray (subjects in France and Netherlands only) • Electroencephalogram (EEG) (in Italy only)	—

Measure

Time frame

—

Secondary

Measure	Time frame
The effectiveness endpoints of the study are: • CGI-I, global and symptomatic, as assessed by parent/caregiver • CGI-I, global and symptomatic, as assessed by investigator (or designee) • Percent improvement in seizure burden as assessed by the investigator (or designee)	—

Countries

Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026