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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fampridine SR | Experimental | 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. |
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| Placebo | Placebo Comparator | Identically looking placebo tablets consisting of widely identical additives formulated for oral administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine SR | Drug | Fampridine SR is an inhibitor of voltage gated potassium channels and is approved in Switzerland for treatment of gait problems in patients with Multiple Sclerosis (MS). |
| Measure | Description | Time Frame |
|---|---|---|
| High-load working-memory performance after repeated administrations (3.5 days) | It will be used the letter n-back task (Heck, Fastenrath et al. 2014)) which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. It will be used parallel versions (different sequences) for the four test days. Primary outcome will be performance after repeated intake of study medication. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| High-load working-memory performance after acute administration | It will be used the letter n-back task (Heck, Fastenrath et al. 2014)) which includes a 3-back task assessing working memory. The 3-back task requires participants to respond to a letter repeat with two intervening letters (for example, S-m-b-s-g…). Performance will be quantified with the d' measure controlling for false positives. It will be administered parallel versions (different sequences) for the four test days. Primary outcome will be performance after repeated intake of study medication. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique de Quervain, Prof. MD | University of Basel, Transfaculty Research Platform | Study Chair |
| Andreas Papassotiropoulos, Prof. MD | University of Basel, Transfaculty Research Platform | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel, Transfaculty Research Platform | Basel | Canton of Basel-City | 4055 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39516710 | Derived | Papassotiropoulos A, Freytag V, Schicktanz N, Gerhards C, Aerni A, Faludi T, Amini E, Muggler E, Harings-Kaim A, Schlitt T, de Quervain DJ. The effect of fampridine on working memory: a randomized controlled trial based on a genome-guided repurposing approach. Mol Psychiatry. 2025 May;30(5):2085-2094. doi: 10.1038/s41380-024-02820-1. Epub 2024 Nov 8. |
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All IPD (de-identified) that underline 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 underline 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. Request will be reviewed by the team of the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2022 | Apr 19, 2022 | Prot_SAP_001.pdf |
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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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| 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 |
| Reaction time after acute and repeated intake | Reaction time for correct answers in the 3-back (d') task (see outcomes 1 and 2) | 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 |
| Attention after acute and repeated administration | Performance in a 0-back task (d' measure controlled). It will be used parallel versions (different sequences) for the four test days. | first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition |
| Symbol Digit Modalities Test (SDMT; Smith 1973) after acute and repeated intake | 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 pseudo-randomized 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 (max. 110). The administration of SDMT will be preceded by a learning sequence at both timepoints. It will be used parallel versions for all test days. | first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition |
| Fluid intelligence (Gf): Bochumer Matrizentest (BOMAT) | Bochumer Matrizentest (BOMAT - advanced -short; Hossiep/Turck/Hasella, 2001, 1st edition), matrix reasoning. It will be administered the BOMAT to measure fluid intelligence (Gf) consisting of 20 items (maximum 20 correct answers possible). Parallel versions will be used for the four test days. It will be used a time-limited version according to Jaeggi (Jaeggi 2010). | first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition |
| Working-memory: Digit Span Task | Working memory will be also assessed with the 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. Parallel version will be used for the four test days. | first and last day of treatment periods (each 4 hours after intake in the morning); to assess differences between the Verum and Placebo condition |
| Resting motor threshold (rMT) | The resting motor threshold (rMT) will be measured by transcranial magnetic stimulation (TMS). rMT will be determined by measuring the motor evoked potential (MEP) in the abductor digiti minimi according to Rossini (2001). rMT will be defined as the lowest stimulation intensity by stimulating the primary motor cortex of the left or right hemisphere required to induce an MEP in the abductor digiti minimi of the dominant hand in at least 5 out of 10 trials. | 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |