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ClinicalTrials.gov public records Last synced Oct 2, 2026, 3:54 PM EDT

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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Fenfluramine treatment (Fintepla) Clear all
Completed Phase 3 Interventional Results available

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

NCT03936777
View directory record Official record
Conditions
Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy
Interventions
ZX008 (Fenfluramine Hydrochloride)
Drug
Lead sponsor
Zogenix, Inc.
Industry
Eligibility
2 Years and older
Enrollment
412 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
26
States / cities
Tucson, Arizona • Los Angeles, California • San Diego, California + 23 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2025 · Synced Oct 2, 2026, 3:54 PM EDT
Enrolling by invitation No phase listed Observational

EEG Dynamics in Lennox-Gastaut Syndrome Patients Undergoing Fenfluramine Treatment

NCT07555171
View directory record Official record
Conditions
Lennox Gastaut Syndrome (LGS)
Interventions
fenfluramine HCl
Drug
Lead sponsor
University of Chicago
Other
Eligibility
2 Years to 35 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Aug 6, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

NCT06118255
View directory record Official record
Conditions
Dravet Syndrome
Interventions
fenfluramine
Drug
Lead sponsor
UCB BIOSCIENCES, Inc.
Industry
Eligibility
1 Year to 23 Months
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
3
States / cities
Memphis, Tennessee • Dallas, Texas • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Recruiting Phase 3 Interventional

A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome

NCT07503444
View directory record Official record
Conditions
Rett Syndrome
Interventions
fenfluramine hydrochloride, Placebo
Drug · Other
Lead sponsor
UCB BIOSCIENCES, Inc.
Industry
Eligibility
5 Years to 35 Years
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
8
States / cities
Little Rock, Arkansas • Miami, Florida • Orlando, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional Results available

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

NCT02682927
View directory record Official record
Conditions
Dravet Syndrome, Seizure Disorder
Interventions
ZX008 (Fenfluramine Hydrochloride), Matching Placebo
Drug
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry
Eligibility
2 Years to 18 Years
Enrollment
262 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
19
States / cities
Phoenix, Arizona • Tucson, Arizona • San Diego, California + 15 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2023 · Synced Oct 2, 2026, 3:54 PM EDT
Recruiting Phase 4 Interventional

The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project

NCT07112365
View directory record Official record
Conditions
Dravet Syndrome
Interventions
Fenfluramine treatment (Fintepla), Hypercapnia Challenge using the device (RespirAct)
Drug · Device
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
16 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 1 Interventional

A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol

NCT03467113
View directory record Official record
Conditions
Dravet Syndrome, Lennox Gastaut Syndrome
Interventions
ZX008 0.2 to 0.8 mg/kg/day, Cannabidiol
Drug
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry
Eligibility
2 Years to 18 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
2
States / cities
Atlanta, Georgia • Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated Dec 1, 2023 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 2 Interventional Results available

Fenfluramine in CDKL5 Deficiency Disorder (CDD)

NCT03861871
View directory record Official record
Conditions
CDD
Interventions
Fenfluramine Hydrochloride
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
2 Years to 18 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 4, 2023 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional Results available

Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).

NCT03790137
View directory record Official record
Conditions
Photosensitive Epilepsy
Interventions
Fenfluramine Hydrochloride
Drug
Lead sponsor
Elizabeth Anne Thiele
Other
Eligibility
4 Years to 25 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 6, 2024 · Synced Oct 2, 2026, 3:54 PM EDT
Recruiting Phase 2 Interventional

Treatment of Refractory Infantile Spasms With Fenfluramine

NCT04289467
View directory record Official record
Conditions
Infantile Spasm
Interventions
Fenfluramine
Drug
Lead sponsor
Children's Hospital of Orange County
Other
Eligibility
12 Months to 36 Months
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
2
States / cities
Los Angeles, California • Orange, California
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants

NCT06679413
View directory record Official record
Conditions
Healthy Study Participants
Interventions
midazolam, metformin, bupropion, fenfluramine HCl
Drug
Lead sponsor
UCB BIOSCIENCES, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
22 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 2, 2026 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional Results available

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

NCT02823145
View directory record Official record
Conditions
Dravet Syndrome
Interventions
ZX008 (Fenfluramine Hydrochloride)
Drug
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry
Eligibility
2 Years to 35 Years
Enrollment
375 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2023
U.S. locations
24
States / cities
Phoenix, Arizona • Tucson, Arizona • Orange, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 14, 2025 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional Results available

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

NCT03355209
View directory record Official record
Conditions
Lennox Gastaut Syndrome
Interventions
ZX008 0.2 or 0.8 mg/kg/day, Matching Placebo
Drug
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry
Eligibility
2 Years to 35 Years
Enrollment
296 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
30
States / cities
Tucson, Arizona • Los Angeles, California • San Francisco, California + 26 more
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Oct 2, 2026, 3:54 PM EDT
Completed Phase 3 Interventional Results available

A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome

NCT02926898
View directory record Official record
Conditions
Dravet Syndrome
Interventions
ZX008 (Fenfluramine Hydrochloride), Matching Placebo
Drug
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry
Eligibility
2 Years to 18 Years
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
5
States / cities
San Francisco, California • Aurora, Colorado • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2022 · Synced Oct 2, 2026, 3:54 PM EDT
Recruiting Phase 4 Interventional

Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age

NCT06598449
View directory record Official record
Conditions
Dravet Syndrome (DS), Children Under 2 Years
Interventions
fenfluramine
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
12 Months to 24 Months
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated May 15, 2026 · Synced Oct 2, 2026, 3:54 PM EDT