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

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ClinicalTrials.gov Identifier: NCT04516603
Recruitment Status : Withdrawn (Changement of study design. Restart spring 2021.)
First Posted : August 18, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel

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.


Condition or disease Intervention/treatment Phase
Working Memory Drug: Fampridine SR Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 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.

Drug: 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 Comparator: Placebo
Identically looking placebo tablets consisting of the identical additives formulated for oral administration.
Drug: Placebo
no active component




Primary Outcome Measures :
  1. Medium-load working memory performance [ Time Frame: test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]

    Accuracy as assessed by a letter n-back task (Papassotiropoulos, Henke et al. 2011) with the levels 0-back and 2-back.

    This test includes a 2-back task assessing working memory and a 0-back task ('x-target' task) measuring concentration. The 2-back task requires participants to respond to a letter repeat with one intervening letter (for example, S-m-s-g…). The 'x-target' task requires participants to respond to the occurrence of the letter 'x' in a sequence of letters (for example, N-l-X-g…). Accuracy (i.e. correct 2-back responses minus correct 0-back responses) will be calculated.



Secondary Outcome Measures :
  1. Reaction time [ Time Frame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]
    Reaction time for correct 2-back responses minus correct 0-back responses.

  2. N-back with a 3-back condition [ Time Frame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]
    N-back with a 3-back condition, which is more demanding than the 2-back condition. Accuracy (3-back minus 0-back) will be calculated.

  3. Symbol Digit Modalities Test, SDMT [ Time Frame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]
    Symbol Digit Modalities Test, SDMT (Smith 2013, 13th edition), a processing speed test. The test consists of the presentation of a series of 9 symbols, each of them is paired with a single digit, labeled 1-9, in a key at the top of a sheet. The remainder of the page has a pseudorandomized sequence of the symbols and the participant must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds. The administration of SDMT will be preceded by a learning sequence at both timepoints. A parallel version will be used for the second test day.

  4. Bochumer Matrizentest (BOMAT - advanced -short) [ Time Frame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]
    Bochumer Matrizentest (BOMAT - advanced -short; Hossiep/Turck/Hasella, 2001, 1st edition), matrix reasoning. The BOMAT will be administered to measure fluid intelligence (Gf) consisting of 29 items. A time-limited version will be used according to Jaeggi (Jaeggi 2010). The total score is calculated by summing the correct solutions, ranging between 0 to 29. A parallel version will be used for the second test day.

  5. Digit Span Task [ Time Frame: test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition ]
    Digit span task, a subtest of the "Wechsler Intelligenztest für Erwachsene" (WIE;von Aster 2006). Total scores for digit span forward and backward will be calculated as described in the manual of the WIE. A parallel version will be used for the second test day.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516603


Locations
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Switzerland
University of Basel, Transfaculty Research Platform
Basel, BS, Switzerland, 4055
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Dominique de Quervain, Prof University of Basel, Transfaculty Research Platform
Study Chair: Andreas Papassotiropoulos, Prof University of Basel, Transfacutly Research Platform
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Responsible Party: Prof. Dominique de Quervain, MD, Director Division of Cognitive Neuroscience, University of Basel
ClinicalTrials.gov Identifier: NCT04516603    
Other Study ID Numbers: 2020-01626
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: IPD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.
Access Criteria: All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Requests will be reviewed by the team of the principle investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action