Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral Sclerosis
This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.
One of the major disease features of ALS is the progressive death of motor neurons. Human,
rodent and stem cell-based model studies support the hypothesis that neuronal
hyperexcitability may contribute to neurodegeneration in both sporadic and familial ALS. The
investigators are doing this research study to find out whether retigabine will reduce motor
neuron excitability in people with ALS. the investigators will also determine whether the
drug is tolerable and safe for patients with ALS.
The proposed study will determine how the potassium channel opener ezogabine (retigabine)
affects neurophysiological measures of upper and lower motor neuron excitability in ALS
patients as assessed by transcranial magnetic stimulation (TMS) and threshold tracking nerve
conduction studies (TTNCS), respectively. The study will include the recruitment of
approximately 60 unmatched healthy control subjects for analysis of variability of the
neurophysiological tests prior to recruitment of ALS subjects. There will also be 12 matched
healthy control subjects, recruited at the same time as ALS subjects.
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