Multiple SclerosisPhase 4NCT02259361
Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
A Phase 4 study testing Sustained-release oral dalfampridine in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Sustained-release oral dalfampridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Nov 2014
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have the ability to understand the purpose and risks of the study provide a signed and dated informed consent and authorize confidential health information to be examined in accordance with national and local subject privacy regulations.
- The patient must have been diagnosed with clinically definite MS, at the time of informed consent.
- The patient must be between 18-70 years of age, inclusive, at the time of informed consent.
- The patient must have scored between 50 and 90 on the upper limb Motricity Index test, at the time of informed consent. This test evaluates strength during three essential movements (pinch grasp, elbow flexion and shoulder abduction). The selected score range criteria determine patients who suffer a moderate decline in function abilities of the upper limb.
Who cannot join
- Onset of multiple sclerosis exacerbation within 60 days of screening.
- History of seizures or evidence of epileptic form activity found on a screened electroencephalogram.
- Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Multiple Sclerosis Center
Tel HaShomer, Ramat-gan
Alon Kalron, PhD, 972-52-2436839, alkalron@gmail.com
About this study
Official title: Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.
Read the detailed description
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks potassium channels on demyelinated neurons, allows normal electrical conduction.
Dalfampridine has recently been found to be associated with improvements in visual function, strength, ambulation, fatigue, and endurance in individuals with MS.
Although this medication has a widespread effect, its influence on upper extremity function has never been investigated in a double blind randomized case control study.
Following the fact that during the disease course, approximately 3 out of 4 multiple sclerosis patients encounter upper limb dysfunction the primary objective of this study will be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity function in patients with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Sustained-release oral dalfampridine, Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained-release oral dalfampridineDrug
Also called Prolonged-release Fampridine, Ampyra
One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
PlaceboDrug
Also called Active comparator
Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Intervention: Sustained-release oral dalfampridine, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days. Receives: Drug: Sustained-release oral dalfampridine |
| Placebo | Placebo comparator | Placebo, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Measured: Changes in the Nine-Hole Peg Test from Baseline to end of Second week
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Measured: Changes in the Nine-Hole Peg Test from Baseline to end of first week
Nine-Hole Peg Test
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Measured: Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
Secondary outcomes (12)
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Measured: Changes in the Box and Block Test from Baseline to end of Second week
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Measured: Changes in the Box and Block Test from Baseline to end of first week
Box and Block test
The box and blocks test (BBT) examines manual dexterity
Measured: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
Measured: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
Measured: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
Isometric grip force and motor fatigue
Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
Measured: Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Measured: Changes in the Sensory evaluation Test from Baseline to end of Second week
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Measured: Changes in the Sensory evaluation Test from Baseline to end of first week
Sensory evaluation
The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
Measured: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Measured: Changes in the DASH Test from Baseline to end of Second week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Measured: Changes in the DASH Test from Baseline to end of first week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
Measured: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anat Achiron, MD, PhD, Study director, Multiple Sclerosis Center, Sheba Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259361
- Sponsor's protocol ID
- SHEBA-13-0380-AA-CTIL
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.
PubMed 17401746Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.
PubMed 16472864Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
PubMed 19249634van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.
PubMed 1510353Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8. doi: 10.1212/wnl.41.9.1344.
PubMed 1891078Menascu S, Frid L, Kalron A. Sustained-release oral dalfampridine appears to have no impact on upper extremity function in people with multiple sclerosis: a randomized controlled trial. Ther Adv Neurol Disord. 2025 Feb 21;18:17562864251321696. doi: 10.1177/17562864251321696. eCollection 2025.
PubMed 39990866
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT02259361
- Acronym / sponsor ID
- SHEBA-13-0380-AA-CTIL
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- 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.
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized pilot study half of participants will dalfampridine, while the other half will receive a placebo.
Detailed description
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks potassium channels on demyelinated neurons, allows normal electrical conduction.
Dalfampridine has recently been found to be associated with improvements in visual function, strength, ambulation, fatigue, and endurance in individuals with MS.
Although this medication has a widespread effect, its influence on upper extremity function has never been investigated in a double blind randomized case control study.
Following the fact that during the disease course, approximately 3 out of 4 multiple sclerosis patients encounter upper limb dysfunction the primary objective of this study will be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity function in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: Sustained-release oral dalfampridineIntervention: Sustained-release oral dalfampridine, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have the ability to understand the purpose and risks of the study provide a signed and dated informed consent and authorize confidential health information to be examined in accordance with national and local subject privacy regulations.
- The patient must have been diagnosed with clinically definite MS, at the time of informed consent.
- The patient must be between 18-70 years of age, inclusive, at the time of informed consent.
- The patient must have scored between 50 and 90 on the upper limb Motricity Index test, at the time of informed consent. This test evaluates strength during three essential movements (pinch grasp, elbow flexion and shoulder abduction). The selected score range criteria determine patients who suffer a moderate decline in function abilities of the upper limb.
Key exclusion criteria (3 listed)
- Onset of multiple sclerosis exacerbation within 60 days of screening.
- History of seizures or evidence of epileptic form activity found on a screened electroencephalogram.
- Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.
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 |
|---|---|---|
| Sustained-release oral dalfampridineAlso: Prolonged-release Fampridine, AmpyraOne Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days. | Drug | Experimental |
| PlaceboAlso: Active comparatorPlacebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days. | Drug | Placebo |
Primary outcome
Nine-Hole Peg Test
Time frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Nine-Hole Peg Test
Time frame: Changes in the Nine-Hole Peg Test from Baseline to end of first week
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
Nine-Hole Peg Test
Time frame: Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
12 secondary outcomes
Box and Block test
Time frame: Changes in the Box and Block Test from Baseline to end of Second week
Box and Block test
Time frame: Changes in the Box and Block Test from Baseline to end of first week
Box and Block test
Time frame: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
Isometric grip force and motor fatigue
Time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
Isometric grip force and motor fatigue
Time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
Isometric grip force and motor fatigue
Time frame: Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase
Sensory evaluation
Time frame: Changes in the Sensory evaluation Test from Baseline to end of Second week
Sensory evaluation
Time frame: Changes in the Sensory evaluation Test from Baseline to end of first week
Sensory evaluation
Time frame: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Changes in the DASH Test from Baseline to end of Second week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Changes in the DASH Test from Baseline to end of first week
Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- Background: PubMed 17401746Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.
- Background: PubMed 16472864Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.
- Background: PubMed 19249634Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
- Background: PubMed 1510353van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.
- Background: PubMed 1891078Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8. doi: 10.1212/wnl.41.9.1344.
- Derived from this study: PubMed 39990866Menascu S, Frid L, Kalron A. Sustained-release oral dalfampridine appears to have no impact on upper extremity function in people with multiple sclerosis: a randomized controlled trial. Ther Adv Neurol Disord. 2025 Feb 21;18:17562864251321696. doi: 10.1177/17562864251321696. eCollection 2025.
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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.
Anat Achiron, MD, PhD study director
Multiple Sclerosis Center, Sheba Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sustained-release oral dalfampridine in people with Multiple Sclerosis, run by Sheba Medical Center at 1 site in Israel.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2014. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shlomo Noy, MD, PhD (972-3-5305284, Shlomo.noy@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (time frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week). The study lists 3 primary outcomes in all. 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 NCT02259361, which also lists 6 linked publications.
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 8 Oct 2014.