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Cognitive FunctionPhase 4FEN&CognitionNCT05026398

Fenfluramine and Cognition

A Phase 4 study testing Fenfluramine in people with Cognitive Function, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Function
What is being tested?
Fenfluramine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited Kingdom
Study dates
12 Apr 2021to 22 Jun 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 22 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Department of Psychiatry, University of Oxford

    Oxford

Other trials in United Kingdom

About this study

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

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.

Being tested
Fenfluramine, Placebo
Keywords
Drug, Cognition, Dravet Syndrome, 5-HT, Sigma-1, Healthy Volunteers
Medical subject headings
Epilepsies, Myoclonic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FenfluramineDrug

    Also called Fintepla (trade name), Fenfluramine Hydrochloride (ZX008)

    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.

  • PlaceboOther

    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

Study groups in NCT05026398
Study groupRoleWhat they receive
FenfluramineExperimentalDrug: Fenfluramine - 15mg twice daily oral solution for seven days
Receives: Drug: Fenfluramine
PlaceboPlacebo comparatorPlacebo - 15mg twice daily oral solution for seven days
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Go/No-Go Task performance

    Accuracy on the Go/No-Go task

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

  2. Change in Auditory Verbal Learning Task

    Accuracy on AVLT (number of items recalled across blocks)

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

  3. Change in N-back task performance

    Accuracy on the N-back task

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

Secondary outcomes (8)

  1. Changes in reward sensitivity

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

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

  2. Changes in categorisation of emotional words

    Accuracy to categorise positive and negative descriptor words

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

  3. Changes in recall of emotional words

    Number of words accurately recalled

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

  4. Changes in recognition of emotional words

    Number of words accurately recognised

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

  5. Changes in recognition of emotional facial expressions

    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.

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

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

    Accuracy on the Oxford Memory Task

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

  7. Changes in visual search ability

    Accuracy during contextual cueing task (CCT)

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

  8. Changes in control measures of subjective state

    Ratings on the Positive and Negative Affect Schedule

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start12 Apr 2021
  3. Primary completion22 Jun 2022
  4. Study completion22 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly allocated to one of two groups (fenfluramine or placebo), stratified on group allocation, gender and cognitive task version administered. Participants in the fenfluramine group will receive oral solution of fenfluramine 15mg twice daily (BID) for seven days. Participants in the placebo group will receive a placebo oral solution 15mg twice daily (BID) for seven days. The study is assessing the effects of fenfluramine on cognitive ability, it is not an efficacy or safety study.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026398
Sponsor's protocol ID
FenCog
Acronym
FEN&Cognition
Status last verified
Nov 2022
First submitted
25 Jun 2021
Last updated
15 Nov 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data which has been fully de-identified may be shared with other academic and commercial organisations in the future, including those outside of the UK and the EU. Participants will be informed of this and specific consent to this is obtained within the Informed Consent Form.

Publications

  • Colwell MJ, Tagomori H, Shang F, Cheng HI, Wigg CE, Browning M, Cowen PJ, Murphy SE, Harmer CJ. Direct serotonin release in humans shapes aversive learning and inhibition. Nat Commun. 2024 Aug 9;15(1):6617. doi: 10.1038/s41467-024-50394-x.

    PubMed 39122687

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fenfluramine in people with Cognitive Function, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Go/No-Go Task performance (time frame: Immediately before initial dose (Day 1) and immediately before final visit (Day 7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05026398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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