Influence of Fampridine on Working Memory in Healthy Young Subjects (FamH)

Prof. Dominique de Quervain, MD

Status and phase: Completed; Phase 2

Conditions: Working Memory

Treatments: Drug: Fampridine SR; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04652557

2020-02828

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Fampridine SR

Experimental group

Description:

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.

Treatment:

Drug: Fampridine SR

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo