Clinical trial NCT02259361: Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
Official title: Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week
measure: Nine-Hole Peg Test
timeFrame: Changes in the Nine-Hole Peg Test from Baseline to end of first week
measure: Nine-Hole Peg Test
timeFrame: Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
Secondary outcomes:
measure: Box and Block test
timeFrame: Changes in the Box and Block Test from Baseline to end of Second week
measure: Box and Block test
timeFrame: Changes in the Box and Block Test from Baseline to end of first week
measure: Box and Block test
timeFrame: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
measure: Isometric grip force and motor fatigue
timeFrame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
measure: Isometric grip force and motor fatigue
timeFrame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
measure: Isometric grip force and motor fatigue
timeFrame: 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
measure: Sensory evaluation
timeFrame: Changes in the Sensory evaluation Test from Baseline to end of Second week
measure: Sensory evaluation
timeFrame: Changes in the Sensory evaluation Test from Baseline to end of first week
measure: Sensory evaluation
timeFrame: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Changes in the DASH Test from Baseline to end of Second week
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Changes in the DASH Test from Baseline to end of first week
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase
Other outcomes:
Locations:
city: Tel-hashomer
country: Israel
facility: Multiple Sclerosis Center
state: Ramat-gan
Study officials:
affiliation: Multiple Sclerosis Center, Sheba Medical Hospital
name: Anat Achiron, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.