Clinical trial NCT04652557: Influence of Fampridine on Working Memory in Healthy Young 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: COMPLETED
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: 2020-12-03
Enrollment: 44
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 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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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
* 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
* experiencing a syncope during basal rMT measuring
* metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.)
* implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)
* cardiac pacemaker or intracardiac lines
* medication infusion device
* piercings, pivot teeth (retainers are no exclusion criterion)
* tattoos (head area) less than 3 months old or older than 20 years
* condition after neurosurgery
* hearing problems or tinnitus
* not able to sit still due to tremor, tics, itching
* history of repeated syncope
* head trauma diagnosed as concussion or associated with loss of consciousness
* diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his family
* TMS in the past showing problems
* MRI in the past showing problems
* surgical procedures to spinal cord
* spinal or ventricular derivations

Primary outcomes:
measure: High-load working-memory performance after repeated administrations (3.5 days)
timeFrame: 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:
measure: High-load working-memory performance after acute administration
timeFrame: 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
measure: Reaction time after acute and repeated intake
timeFrame: 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
measure: Attention after acute and repeated administration
timeFrame: first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition
measure: Symbol Digit Modalities Test (SDMT; Smith 1973) after acute and repeated intake
timeFrame: first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition
measure: Fluid intelligence (Gf): Bochumer Matrizentest (BOMAT)
timeFrame: first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition
measure: Working-memory: Digit Span Task
timeFrame: first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition
measure: Resting motor threshold (rMT)
timeFrame: test days 2 and 4 (last day of treatment periods; approx. 5 hours after last intake of fampridine SR) 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. MD
role: STUDY_CHAIR
affiliation: University of Basel, Transfaculty Research Platform
name: Andreas Papassotiropoulos, Prof. MD
role: STUDY_CHAIR
References: