Influence of Fampridine on Working Memory in Healthy Subjects
NCT ID: NCT04516603
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2040-01-01
2041-12-31
Brief Summary
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The hypotheses is that fampridine improves working memory performance.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Fampridine SR
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.
Fampridine SR
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).
Placebo
Identically looking placebo tablets consisting of the identical additives formulated for oral administration.
Placebo
no active component
Interventions
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Fampridine SR
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).
Placebo
no active component
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* participation in another study with an investigational drug within the 30 days preceding and during the present study
* prior participation (less than two years ago) in a study investigating working memory (notably the n-back task)
* enrolment of the investigator, his/her family members, employees and other dependent persons
* smoking (\>3 cigarettes per day)
* intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics)
* pregnancy or breast feeding
18 Years
30 Years
ALL
Yes
Sponsors
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Clinical Trial Unit, University Hospital Basel, Switzerland
OTHER
University Hospital, Basel, Switzerland
OTHER
Prof. Dominique de Quervain, MD
OTHER
Responsible Party
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Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
Principal Investigators
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Dominique de Quervain, Prof
Role: STUDY_CHAIR
University of Basel, Transfaculty Research Platform
Andreas Papassotiropoulos, Prof
Role: STUDY_CHAIR
University of Basel, Transfacutly Research Platform
Locations
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University of Basel, Transfaculty Research Platform
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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2020-01626
Identifier Type: -
Identifier Source: org_study_id