Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Sustained-release oral dalfampridine

Study type: Interventional

Funder types: Other

Identifiers

NCT02259361

SHEBA-13-0380-AA-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental

Active Comparator group

Description:

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.

Treatment:

Drug: Sustained-release oral dalfampridine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo