Influence of Fampridine on Working Memory in Healthy Young Subjects

NCT04652557 | Completed Phase 2

• 1 other identifier: 2020-02828
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Proof of concept study on the acute effects on working memory of 10 mg fampridine SR as well as the effects after repeated administration of 10 mg twice daily (3.5 days). The hypothesis ist that fampridine improves working memory performance.

Conditions

Working Memory

Outcome Measures

Primary Outcomes (1)

• High-load working-memory performance after repeated administrations (3.5 days)

  It will be used the letter n-back task (Heck, Fastenrath et al. 2014)) which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. It will be used parallel versions (different sequences) for the four test days. Primary outcome will be performance after repeated intake of study medication.

  test days 2 and 4 (end of treatment periods; 4 hours after last intake of fampridine SR) to assess changes between the Verum and Placebo condition

Secondary Outcomes (7)

• High-load working-memory performance after acute administration

  test days 1 and 3 (beginning of treatment periods; 4 hours after first intake of fampridine SR) to assess differences between the Verum and Placebo condition

• Reaction time after acute and repeated intake

  test days 1 and 3 (beginning of treatment periods; 4 hours after first intake of fampridine SR) to assess differences between the Verum and Placebo condition

• Attention after acute and repeated administration

  first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition

• Symbol Digit Modalities Test (SDMT; Smith 1973) after acute and repeated intake

  first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition

• Fluid intelligence (Gf): Bochumer Matrizentest (BOMAT)

  first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition

Study Arms (2)

Fampridine SR

EXPERIMENTAL

Active study medication consists of 7 tablets of fampridine SR 10 mg formulated for oral administration taken in the morning and evening 12 h apart without food. Tablets must be administered whole. There will be a washout period of at least 8 days equaling over 30 half-lives of the active substance fampridine (t½ = 6 h) between experimental and control intervention and up to 82 days depending on the individual scheduling of each subject.

Drug: Fampridine SR

Placebo

PLACEBO COMPARATOR

Identically looking placebo tablets consisting of widely identical additives formulated for oral administration.

Drug: Placebo

Interventions

Fampridine SR DRUG

Fampridine SR is an inhibitor of voltage gated potassium channels and is approved in Switzerland for treatment of gait problems in patients with Multiple Sclerosis (MS).

Fampridine SR

Placebo DRUG

no active component

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male or female
• generally healthy
• normotensive (BP between 90/60mmHg and 140/90mmHg)
• BMI between 19 and 29,9 kg/m2
• aged between 18 and 30 years
• fluent German-speaking
• IC as documented by signature
• at least double vaccination against Covid-19

You may not qualify if:

• contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine
• use of potassium channel blockers within the last 3 months
• concomitant treatment with OCT 2 inhibitors and substrates (e.g. cimetidine, propranolol)
• acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
• acute cerebrovascular condition
• history of seizures
• risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse)
• renal impairment
• history of malignant cancers
• walking problems (e.g. due to dizziness)
• bradycardia \> 50/min during clinical examination
• clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma)
• clinically significant laboratory or ECG abnormality that could be a safety issue in the study
• known or suspected non-compliance
• drug or alcohol abuse

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University of Basel, Transfaculty Research Platform

Basel, Canton of Basel-City, 4055, Switzerland

Location

Related Publications (1)

• Papassotiropoulos A, Freytag V, Schicktanz N, Gerhards C, Aerni A, Faludi T, Amini E, Muggler E, Harings-Kaim A, Schlitt T, de Quervain DJ. The effect of fampridine on working memory: a randomized controlled trial based on a genome-guided repurposing approach. Mol Psychiatry. 2025 May;30(5):2085-2094. doi: 10.1038/s41380-024-02820-1. Epub 2024 Nov 8.

  PMID: 39516710 DERIVED

MeSH Terms

Interventions

4-Aminopyridine

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dominique de Quervain, Prof. MD

  University of Basel, Transfaculty Research Platform

  STUDY CHAIR

• Andreas Papassotiropoulos, Prof. MD

  University of Basel, Transfaculty Research Platform

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Division of Cognitive Neuroscience

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: November 1, 2021
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.
• Access Criteria: All IPD (de-identified) that underline results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Request will be reviewed by the team of the principal investigator.

Locations

CH (1)