Status:
UNKNOWN
Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
Lead Sponsor:
Sheba Medical Center
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 hal...
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 recent...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02259361
Start Date
November 1 2014
End Date
November 1 2014
Last Update
October 8 2014
Active Locations (1)
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1
Multiple Sclerosis Center
Tel Litwinsky, Ramat-gan, Israel