Clinical trial NCT04516603: Influence of Fampridine on Working Memory in Healthy Subjects
Official title: Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Working Memory
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
name: University Hospital, Basel, Switzerland
First posted: 2020-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Medium-load working memory performance
timeFrame: test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
Secondary outcomes:
measure: Reaction time
timeFrame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
measure: N-back with a 3-back condition
timeFrame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
measure: Symbol Digit Modalities Test, SDMT
timeFrame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
measure: Bochumer Matrizentest (BOMAT - advanced -short)
timeFrame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
measure: Digit Span Task
timeFrame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Transfaculty Research Platform
state: BS
Study officials:
affiliation: University of Basel, Transfaculty Research Platform
name: Dominique de Quervain, Prof
role: STUDY_CHAIR
affiliation: University of Basel, Transfacutly Research Platform
name: Andreas Papassotiropoulos, Prof
role: STUDY_CHAIR
References: