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4-Aminopyridine in multiple sclerosis: prolonged administration.

D Stefoski¹, F A Davis, W E Fitzsimmons

¹Rush Multiple Sclerosis Center, Rush University, Chicago, IL 60612.

|September 1, 1991

Summary

Multiple daily doses of 4-aminopyridine (4-AP) safely prolonged motor and visual improvements in multiple sclerosis (MS) patients. This suggests 4-AP is a promising option for managing MS symptoms.

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Area of Science:

Neurology
Clinical Pharmacology

Background:

Previous research demonstrated single oral doses of 4-aminopyridine (4-AP) improve motor and visual signs in multiple sclerosis (MS) patients.
The duration of efficacy from single doses was limited, averaging 4.97 hours.

Purpose of the Study:

To determine if multiple daily doses of 4-AP could safely extend the duration of therapeutic effects in MS patients.
To evaluate the safety and efficacy of varied dosing regimens of 4-AP over several days.

Main Methods:

A double-blind study administered 7.5 to 52.5 mg of 4-AP to 17 temperature-sensitive MS patients.
Dosing involved one to three daily administrations at 3- to 4-hour intervals for 1 to 5 days.
A subset of nine patients also received a placebo for comparison.

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Main Results:

76% of patients receiving 4-AP (13/17) experienced clinically significant motor and visual improvements, compared to 33% on placebo (3/9).
Average peak improvement scores were higher for 4-AP (0.40) versus placebo (0.12).
Improvements from 4-AP lasted significantly longer, with daily improvements lasting 7-10 hours and consecutive doses averaging 7.07 hours of effect.

Conclusions:

Multiple daily doses of 4-AP provide prolonged symptomatic relief for motor and visual deficits in MS patients.
The treatment was well-tolerated, with no serious adverse events reported.
4-AP shows potential as an effective symptomatic treatment for multiple sclerosis.