Influence of Fampridine on Working Memory in Healthy Subjects

NCT04516603 | Withdrawn Phase 2

• 1 other identifier: 2020-01626
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Proof-of-concept study on the effects of 10 mg fampridine (oral administration) on working memory in healthy participants. The hypotheses is that fampridine improves working memory performance.

Conditions

Working Memory

Outcome Measures

Primary Outcomes (1)

• Medium-load working memory performance

  Accuracy as assessed by a letter n-back task (Papassotiropoulos, Henke et al. 2011) with the levels 0-back and 2-back. This test includes a 2-back task assessing working memory and a 0-back task ('x-target' task) measuring concentration. The 2-back task requires participants to respond to a letter repeat with one intervening letter (for example, S-m-s-g…). The 'x-target' task requires participants to respond to the occurrence of the letter 'x' in a sequence of letters (for example, N-l-X-g…). Accuracy (i.e. correct 2-back responses minus correct 0-back responses) will be calculated.

  test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

Secondary Outcomes (5)

• Reaction time

  test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

• N-back with a 3-back condition

  test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

• Symbol Digit Modalities Test, SDMT

  test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

• Bochumer Matrizentest (BOMAT - advanced -short)

  test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

• Digit Span Task

  test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition

Study Arms (2)

Fampridine SR

EXPERIMENTAL

Single oral administration of a tablet fampridine (10 mg) formulated for oral administration taken once in the morning without food. Tablets must be administered whole. The single intake is followed by a washout period of at least 7 days equalling over 40 half-lives of the active substance fampridine (t½ = 3.61 h) between experimental and control intervention.

Drug: Fampridine SR

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fampridine SR DRUG

Fampridine is an inhibitor of voltage-gated potassium (Kv) 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 90/60 mmHg and 140/90 mmHg)
• BMI between 19 and 29,9 kg/m2
• aged between 18 and 30 years
• fluent German-speaking
• Informed consent as documented by signature

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 (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)
• other 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
• inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant

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

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

  University of Basel, Transfaculty Research Platform

  STUDY CHAIR

• Andreas Papassotiropoulos, Prof

  University of Basel, Transfacutly 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: August 11, 2020
• First Posted: August 18, 2020
• Study Start (Estimated): January 1, 2040
• Primary Completion (Estimated): December 31, 2041
• Study Completion (Estimated): December 31, 2041
• Last Updated: December 5, 2024

Record last verified: 2024-12

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 underlie 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. Requests will be reviewed by the team of the principle investigator.

Locations

CH (1)