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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained-release oral dalfampridine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nine-Hole Peg Test | The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function | 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 | 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 | Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Block test | The box and blocks test (BBT) examines manual dexterity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shlomo Noy, MD, PhD | Contact | 972-3-5305284 | Shlomo.noy@sheba.health.gov.il | |
| Alon Kalron, PhD | Contact | 972-2-2436839 | alkalron@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anat Achiron, MD, PhD | Multiple Sclerosis Center, Sheba Medical Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Sclerosis Center | Tel Litwinsky | Ramat-gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17401746 | Background | 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. | |
| 16472864 | Background |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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 | 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. |
|
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase |
| Judge 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. |
| 19249634 | Background | Goodman 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. |
| 1510353 | Background | van 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. |
| 1891078 | Background | Stefoski 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. |
| 39990866 | Derived | Menascu 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |