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Changement of study design. Restart spring 2021. See new registration number: NCT04652557 (FamH)
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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fampridine SR | Experimental | 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. |
|
| Placebo | Placebo Comparator | Identically looking placebo tablets consisting of the identical additives formulated for oral administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine SR | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Medium-load working memory performance | 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. | test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction time | Reaction time for correct 2-back responses minus correct 0-back responses. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique de Quervain, Prof | University of Basel, Transfaculty Research Platform | Study Chair |
| Andreas Papassotiropoulos, Prof | University of Basel, Transfacutly Research Platform | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Transfaculty Research Platform | Basel | Canton of Basel-City | 4055 | Switzerland |
All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request.
IPD will be available after publication, study protocol (including statistical analysis plan) will be made available before start of the study.
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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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Placebo | Drug | no active component |
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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.
| 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 | 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. | 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) | 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. | 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 | 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. | test day 1 and 2 each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |