Fenfluramine and Cognition (FEN&Cognition)

November 14, 2022 updated by: Catherine Harmer, University of Oxford

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 18 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fenfluramine
Drug: Fenfluramine - 15mg twice daily oral solution for seven days
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 Names:
  • Fintepla (trade name)
  • Fenfluramine Hydrochloride (ZX008)
Placebo Comparator: Placebo
Placebo - 15mg twice daily oral solution for seven days
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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)
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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.
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 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)
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)
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
Immediately before initial dose (Day 1) and immediately before final visit (Day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research, United Kingdom
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine J Harmer, DPhil, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FenCog

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

A few months after all data has been completed (ETA Jan 2022), unblinding has occurred (ETA Feb 2022), and all data analyses has been completed (ETA June 2022).

IPD Sharing Access Criteria

The data will be made publicly available. Access requests will not be required.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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