Fenfluramine and Cognition

NCT ID: NCT05026398

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-06-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Fenfluramine

Drug: Fenfluramine - 15mg twice daily oral solution for seven days

Group Type: EXPERIMENTAL

Fenfluramine

Intervention Type: 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.

Placebo

Placebo - 15mg twice daily oral solution for seven days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Fintepla (trade name); Fenfluramine Hydrochloride (ZX008)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Catherine Harmer

Prof Catherine Harmer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine J Harmer, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Department of Psychiatry, University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

FenCog

Identifier Type: -

Identifier Source: org_study_id