Working MemoryPhase 2FamHNCT04652557
Influence of Fampridine on Working Memory in Healthy Young Subjects
A Phase 2 study testing Fampridine SR in people with Working Memory, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Working Memory
- What is being tested?
- Fampridine SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 26 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 39Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Transfaculty Research Platform
Basel, Canton of Basel-City, 4055
About this study
Official title: Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects
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.
- Conditions
- Working Memory
- Being tested
- Fampridine SR, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fampridine SRDrug
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).
PlaceboDrug
no active component
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fampridine SR |
| Placebo | Placebo comparator | Identically looking placebo tablets consisting of widely identical additives formulated for oral administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (7)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Nov 2021
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Working MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, Prof. MD, Study chair, University of Basel, Transfaculty Research PlatformAndreas Papassotiropoulos, Prof. MD, Study chair, University of Basel, Transfaculty Research Platform
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652557
- Sponsor's protocol ID
- 2020-02828
- Acronym
- FamH
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (de-identified) that underline results in a publication will be shared upon reasonable request.
Publications
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.
PubMed 39516710
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Phase II Cross-over Study on the Influence of Fampridine on Working Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04652557
- Acronym / sponsor ID
- FamH / 2020-02828
- Conditions
- Working Memory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, University Hospital, Basel, Switzerland
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fampridine SR | Experimental | Drug: Fampridine SRActive 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. |
| Placebo | Placebo comparator | Drug: PlaceboIdentically looking placebo tablets consisting of widely identical additives formulated for oral administration. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fampridine SRFampridine 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). | Drug | Fampridine SR |
| Placebono active component | Drug | Placebo |
Primary outcome
High-load working-memory performance after repeated administrations (3.5 days)
Time frame: 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
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.
7 secondary outcomes
High-load working-memory performance after acute administration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 39516710Papassotiropoulos 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.
- Individual participant dataSharing planned: Yes. All IPD (de-identified) that underline results in a publication will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique de Quervain, Prof. MD study chair
University of Basel, Transfaculty Research Platform
Andreas Papassotiropoulos, Prof. MD study chair
University of Basel, Transfaculty Research Platform
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fampridine SR in people with Working Memory, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-load working-memory performance after repeated administrations (3.5 days) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.