Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: 4-Aminopyridine

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.