Dalfampridine for Imbalance in Multiple Sclerosis

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis; Fatigue

Treatments: Drug: Placebo; Drug: Dalfampridine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01444300

GNEUR0637A

Details and patient eligibility

About

Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.

Enrollment: 24 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20- 59 years,
• Able to walk at least 100m without an aide or with unilateral assistance
• Prolonged APR latencies (≥ 1SD > mean for healthy people in this age range) OR,
• Reduced balance-related activity (ABC scores ≤ 85%),
• Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1SD of the average for healthy people in this age range)

Exclusion criteria

• Currently taking dalfampridine (any within the last 2 weeks),
• Cause(s) of imbalance other than MS,
• Impaired renal function (creatinine clearance ≤50mL/min),
• Seizure disorder
• Pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Dalfampridine

Experimental group

Treatment:

Drug: Dalfampridine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo