Phase IIB Randomized Trial on the Use of 4-Aminopyridine in Guillain-Barre Syndrome.

ABSTRACT:

Objective

To determine the safety and efficacy of orally delivered 4-aminopyridine (4-AP) in persons with Guillain-Barré Syndrome (GBS) >6 months from initial diagnosis.

Design

A randomized, double-blind, placebo-controlled, crossover study.

Setting

Tertiary care clinical outpatient program.

Participants

Nineteen participants enrolled (14 male, 5 female; N=19), neurologic impairment secondary to GBS and functional loss on the FIM motor score (stable for ≥12mo) and >3.0 but <5.0 on the American Spinal Injury motor scale. Twelve participants (mean age, 59y; range, 23-77y) completed the study.

Interventions

A 4-AP dose-escalation study with 8 weeks in each period with a 3-week washout period, followed by 3 months open-label follow-up.

Main outcome measur

SUBMITTER: Meythaler JM 

PROVIDER: S-EPMC8212006 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature