Fenfluramine

Generic Name
Fenfluramine
Brand Names
Fintepla
Drug Type
Small Molecule
Chemical Formula
C12H16F3N
CAS Number
458-24-2
Unique Ingredient Identifier
2DS058H2CF
Background

Dravet syndrome is a pediatric encephalopathy that typically manifests within the first year of life following exposure to elevated temperatures. It is characterized by recurrent pharmacoresistant seizures, which increase in frequency and severity with disease progression. Concomitantly with these seizures, patients typically display delayed development and ...

Indication

Fenfluramine is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged two years and older.

Associated Conditions
Seizures
Associated Therapies
-
Clinical Trials
Related News

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

Phase 4
Recruiting
Conditions
Dravet Syndrome (DS)
Children Under 2 Years
Interventions
Drug: fenfluramine
First Posted Date
2024-09-19
Last Posted Date
2024-12-10
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
12
Registration Number
NCT06598449
Locations
🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

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

Phase 3
Recruiting
Conditions
Dravet Syndrome
Interventions
Drug: fenfluramine
First Posted Date
2023-11-07
Last Posted Date
2024-12-03
Lead Sponsor
UCB BIOSCIENCES, Inc.
Target Recruit Count
20
Registration Number
NCT06118255
Locations
🇪🇸

Ep0213 601, Barcelona, Spain

🇺🇸

Ep0213 106, Orange, California, United States

🇺🇸

Ep0213 102, Winston-Salem, North Carolina, United States

and more 15 locations

Fenfluramine for Adult Dravet Patients

Phase 3
Not yet recruiting
Conditions
Dravet Syndrome
Dravet Syndrome, Intractable
Interventions
Drug: Fenfluramine
First Posted Date
2022-09-29
Last Posted Date
2022-11-09
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
15
Registration Number
NCT05560282
Locations
🇨🇦

Toronto Western Hospital, Toronto, Ontario, Canada

Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes

First Posted Date
2022-02-10
Last Posted Date
2024-02-28
Lead Sponsor
Hospital Ruber Internacional
Target Recruit Count
20
Registration Number
NCT05232630
Locations
🇪🇸

Hospital Ruber Internacional, Madrid, Spain

Fenfluramine and Cognition

Phase 4
Completed
Conditions
Cognitive Function
Interventions
Other: Placebo
Drug: Fenfluramine
First Posted Date
2021-08-30
Last Posted Date
2022-11-15
Lead Sponsor
University of Oxford
Target Recruit Count
56
Registration Number
NCT05026398
Locations
🇬🇧

Department of Psychiatry, University of Oxford, Oxford, United Kingdom

Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

Conditions
Dravet Syndrome
First Posted Date
2020-06-18
Last Posted Date
2020-06-18
Lead Sponsor
University of California, Los Angeles
Registration Number
NCT04437004
Locations
🇺🇸

University of California, Los Angeles, Los Angeles, California, United States

Treatment of Refractory Infantile Spasms With Fenfluramine

Phase 2
Recruiting
Conditions
Infantile Spasm
Interventions
Drug: Fenfluramine
First Posted Date
2020-02-28
Last Posted Date
2024-02-07
Lead Sponsor
Children's Hospital of Orange County
Target Recruit Count
10
Registration Number
NCT04289467
Locations
🇺🇸

UCLA Health, Los Angeles, California, United States

🇺🇸

Children's Hospital of Orange County, Orange, California, United States

Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

Phase 2
Active, not recruiting
Conditions
Lennox Gastaut Syndrome
Epilepsy
Interventions
Drug: Fenfluramine
First Posted Date
2016-01-13
Last Posted Date
2023-09-22
Lead Sponsor
KU Leuven
Target Recruit Count
13
Registration Number
NCT02655198
Locations
🇧🇪

University Hospitals UZ Leuven, Leuven, Belgium

Cardiovascular System in Obesity: Effect of Treatment

Phase 2
Completed
Conditions
Heart Diseases
Vascular Diseases
Obesity
First Posted Date
1999-10-28
Last Posted Date
2013-11-26
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Registration Number
NCT00000506

Predictive Values of Serotonergic Alterations for Outcome - 2

Phase 1
Terminated
Conditions
Cocaine-Related Disorders
First Posted Date
1999-09-21
Last Posted Date
2017-01-12
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Registration Number
NCT00000313
Locations
🇺🇸

VA Medical Center, Brooklyn, New York, United States

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