Working MemoryPhase 2Fampyr_2020NCT04516603
Influence of Fampridine on Working Memory in Healthy 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 effects of 10 mg fampridine (oral administration) on working memory in healthy participants. The hypotheses is 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
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2040to 31 Dec 2041
- 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 90/60 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
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 (e.g. cimetidine, propranolol)
- acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
- acute cerebrovascular condition
- history of seizures
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- 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 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 effects of 10 mg fampridine (oral administration) on working memory in healthy participants.
The hypotheses is 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 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).
PlaceboDrug
no active component
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fampridine SR |
| Placebo | Placebo comparator | Identically looking placebo tablets consisting of the 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.
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.
Measured: test day 1 and 2, each 4 hours after intake of study medication to assess differences between the Verum and Placebo condition
Secondary outcomes (5)
Reaction time
Reaction time for correct 2-back responses minus correct 0-back responses.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: test day 1 and 2 each 4 hours after intake of study medication 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 posted18 Aug 2020
- Study start1 Jan 2040 (estimated)
- Primary completion31 Dec 2041 (estimated)
- Study completion31 Dec 2041 (estimated)
Why it stopped: Changement of study design. Restart spring 2021. See new registration number: NCT04652557 (FamH)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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, Study chair, University of Basel, Transfaculty Research PlatformAndreas Papassotiropoulos, Prof, Study chair, University of Basel, Transfacutly Research Platform
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516603
- Sponsor's protocol ID
- 2020-01626
- Acronym
- Fampyr_2020
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2020
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. 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
- NCT04516603
- Acronym / sponsor ID
- Fampyr_2020 / 2020-01626
- Conditions
- Working Memory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changement of study design. Restart spring 2021. See new registration number: NCT04652557 (FamH)
- Enrolment
- 0 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 Jan 2040 (estimated)
- Primary completion
- 31 Dec 2041 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 18 Aug 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 effects of 10 mg fampridine (oral administration) on working memory in healthy participants.
The hypotheses is 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 SRSingle 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 | Drug: PlaceboIdentically looking placebo tablets consisting of the 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 (7 listed)
- 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
Key exclusion criteria (21 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 (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 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). | Drug | Fampridine SR |
| Placebono active component | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Yes. All IPD (de-identified) that underlie 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 study chair
University of Basel, Transfaculty Research Platform
Andreas Papassotiropoulos, Prof study chair
University of Basel, Transfacutly 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 7 inclusion and 21 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: withdrawn, as of the sponsor's last update on 5 Dec 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.