NCT05026398 (FEN&Cognition) is a Phase 4 clinical trial of Fenfluramine in Cognitive Function, sponsored by University of Oxford.

Who is sponsoring NCT05026398?

NCT05026398 is sponsored by University of Oxford.

What drugs are being tested in NCT05026398?

Interventions in NCT05026398: Fenfluramine, Placebo.

What condition does NCT05026398 study?

NCT05026398 studies Cognitive Function.

Is NCT05026398 still recruiting?

NCT05026398 is currently completed. Last updated 15 November 2022.

Last reviewed 2022-11-15 · How we verify

NCT05026398: FEN&Cognition

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fenfluramine and Cognition

Completed Phase 4 Last updated 15 November 2022

What this trial tests

Phase 4 trial testing Fenfluramine in Cognitive Function in 56 participants. Completed in 22 June 2022.

Timeline

12 April 2021

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	56
Start date	12 April 2021
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

Fenfluramine (FENFLURAMINE) — full drug profile →
Placebo

Conditions studied

Cognitive Function — all drugs for Cognitive Function →

Sponsor

University of Oxford

Who can join

Adults 18 to 22, any sex, with Cognitive Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, the investigators will investigate the cognitive effects of fenfluramine, a drug that directly stimulates the release of serotonin in the brain and positively modulates σ1 function. The investigators will use fenfluramine to assess the cognitive effects of modulating serotonin and σ1 function in healthy volunteers using a battery of cognitive tasks that measure learning and memory, executive functioning, reward processing, and emotional processing. The study design is double-blind, and participants will be randomised to either seven days of fenfluramine or placebo administration. All participants will attend two screening visits to assess eligibility. There are two main study visits; during the first, participants will undertake cognitive tasks and questionnaires before taking the initial study dose. One the second study visit, participants will once again complete these tasks and questionnaires after a week of fenfluramine/placebo administration.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Direct serotonin release in humans shapes aversive learning and inhibition.
Colwell MJ, Tagomori H, Shang F, Cheng HI, et al · · 2024 · cited 13× · PMID 39122687 · DOI 10.1038/s41467-024-50394-x
Direct serotonin release in humans shapes decision computations within aversive environments
Colwell MJ, Tagomori H, Shang F, Cheng H, et al · · 2023 · DOI 10.1101/2023.09.30.560111

Verify or expand the search:

Other trials of Fenfluramine

Trials testing the same drug.

NCT04289467 — Treatment of Refractory Infantile Spasms With Fenfluramine · Phase 2 · recruiting
NCT05560282 — Fenfluramine for Adult Dravet Patients · Phase 3 · unknown
NCT05232630 — Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Explori · Phase 4 · unknown
NCT00000313 — Predictive Values of Serotonergic Alterations for Outcome - 2 · Phase 1 · terminated
NCT04437004 — Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol) · available

Other recruiting trials for Cognitive Function

Currently open trials in the same condition.

NCT07586696 — Effects of Exercise Board Games on Cognitive Function in Older Adults · NA · active not recruiting
NCT07245784 — Radicle Clarity™ RBB: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Hea · NA · recruiting
NCT07103343 — MOVI-OLE! [Open Learning Environments] · NA · active not recruiting
NCT07312435 — B-vitamins and Omega-3 Fatty Acids and Biomarkers of Brain Atrophy. · NA · recruiting
NCT07139210 — EFFECT OF PERCEPTUAL-MOTOR TRAINING ON COGNITIVE FUNCTIONS, MOTOR ABILITIES AND QUALITY OF LIFE IN CHILDREN WITH ATTENTI · NA · active not recruiting

Other University of Oxford trials

Trials by the same sponsor.

NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05026398 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oxford
Last refreshed: 15 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05026398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing