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Completed

NCT Number: NCT05026398

Fenfluramine and Cognition

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.

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Key information

Conditions

Cognitive Function Brain Diseases Central Nervous System Diseases Epilepsies, Myoclonic Epilepsy Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, University of Oxford

Oxford, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is willing and able to give informed consent for participation in the research
  • Not currently taking any medications (except the contraceptive pill)
  • Aged 18-22 years
  • Male or female
  • Sufficiently fluent English to understand and complete the task
  • Body Mass Index above 18-30
  • Weight of 40-75kg

Exclusion criteria

  • Current pregnancy (as determined by urine pregnancy test taken during Screening and First Dose Visit) or breast feeding
  • Any past or current Axis 1 DSM-V psychiatric disorder
  • Clinically significant abnormal values for liver function tests, clinical chemistry, urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
  • History of, or current medical conditions which, in the opinion of the investigator, may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
  • Current or past history of drug or alcohol dependency
  • Current or past use of 3,4-Methylenedioxymethamphetamine (MDMA)
  • Use of recreational drugs (e.g. cannabis, cocaine, amphetamines) within past 3 months
  • Participation in a study which uses the same computer tasks as those in the present study (determined by asking participants about previous studies participated in during screening)
  • Participation in a study that involves the use of a medication within the last three months
  • Smoking > 5 cigarettes per day
  • Typically drinks > 6 caffeinated drinks per day (e.g. tea, coffee, coca cola, Red Bull)
  • Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator

Treatment and study plan

fenfluramine

Drug

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 names: Fintepla (trade name), Fenfluramine Hydrochloride (ZX008)

Placebo

Other

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

Primary outcomes

  1. Change in Go/No-Go Task performance

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy on the Go/No-Go task

  2. Change in Auditory Verbal Learning Task

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy on AVLT (number of items recalled across blocks)

  3. Change in N-back task performance

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy on the N-back task

Secondary outcomes

  1. Changes in reward sensitivity

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Sensitivity to reward as measured by the Probabilistic Instrumental Learning Task (PILT)

  2. Changes in categorisation of emotional words

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy to categorise positive and negative descriptor words

  3. Changes in recall of emotional words

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Number of words accurately recalled

  4. Changes in recognition of emotional words

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Number of words accurately recognised

  5. Changes in recognition of emotional facial expressions

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy of emotion labels (e.g. disgusted face) assigned by participants to expressive faces which have appeared on a computer screen for a period of 500ms.

  6. Changes in visual short term memory on the Oxford Memory Test (OMT)

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy on the Oxford Memory Task

  7. Changes in visual search ability

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Accuracy during contextual cueing task (CCT)

  8. Changes in control measures of subjective state

    Time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

    Ratings on the Positive and Negative Affect Schedule

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Registry information

Official study title

The Effect of Seven Day Fenfluramine Administration on Cognition in Healthy Volunteers

Acronym: FEN&Cognition

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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