Influence of Fampridine on Working Memory in Healthy Subjects (Fampyr_2020)

Prof. Dominique de Quervain, MD

Status and phase: Withdrawn; Phase 2

Conditions: Working Memory

Treatments: Drug: Fampridine SR; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04516603

2020-01626

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Fampridine SR

Experimental group

Description:

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.

Treatment:

Drug: Fampridine SR

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo