Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Placebo or sham
- Placebo
What it measured
Main measures
Nine-Hole Peg Test
Changes in the Nine-Hole Peg Test from Baseline to end of Second week
Arm and hand functionNine-Hole Peg Test
Changes in the Nine-Hole Peg Test from Baseline to end of first week
Arm and hand functionNine-Hole Peg Test
Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
Arm and hand function
Other measures (12)
Box and Block test
Changes in the Box and Block Test from Baseline to end of Second week
Arm and hand functionBox and Block test
Changes in the Box and Block Test from Baseline to end of first week
Arm and hand functionBox and Block test
Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
Arm and hand functionIsometric grip force and motor fatigue
Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
FatigueArm and hand functionPhysical functionIsometric grip force and motor fatigue
Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
FatigueArm and hand functionPhysical functionIsometric grip force and motor fatigue
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
FatigueArm and hand functionPhysical functionSensory evaluation
Changes in the Sensory evaluation Test from Baseline to end of Second week
Sensory evaluation
Changes in the Sensory evaluation Test from Baseline to end of first week
Sensory evaluation
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)
Changes in the DASH Test from Baseline to end of Second week
Arm and hand function
Who could take part
MS (type not specified) · 18 to 70
Inclusion Criteria: 1. 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. 2. The patient must have been diagnosed with clinically definite MS, at the time of informed consent. 3. The patient must be between 18-70 years of age, inclusive, at the time of informed consent. 4. 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. Exclusion Criteria: 1. Onset of multiple sclerosis exacerbation within 60 days of screening. 2. History of seizures or evidence of epileptic form activity found on a screened electroencephalogram. 3. Changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.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.Background
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.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.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.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.
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History
Started
Nov 2014
Main results due
Nov 2014
Finished
Nov 2014
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