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Fenfluramine and Cognition

NCT05026398 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-11-15

No results posted yet for this study

Summary

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.

Conditions

  • Cognitive Function

Interventions

DRUG

Fenfluramine

Fenfluramine (30mg daily) will be dispensed in a cherry flavoured aqueous solution. Fenfluramine is both a serotonin releasing agent and sigma-1 receptor agonist. Fenfluramine is FDA approved for the treatment of Dravet syndrome, a rare form of epilepsy.

OTHER

Placebo

The placebo is a liquid designed to be identical to the interventional drug fenfluramine in terms of both taste and visual appearance. It will be administered at 30mg daily and dispensed in a cherry flavoured aqueous solution

Sponsors & Collaborators

  • Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

    collaborator INDUSTRY

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Catherine J Harmer, DPhil · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2022-06-22
Completion
2022-06-22
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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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 NCT05026398 on ClinicalTrials.gov