Last updated on February 2018

Clinical Trial of Ezogabine (Retigabine) in ALS Subjects

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02450552

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Shafeeq Ladha, MD

Barrow Neuological Institute
Phoenix, AZ United States
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Robert Baloh, MD

Los Angeles, CA United States
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Namita Goyal, MD

UC Irvine Medical Center
Orange, CA United States
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Kevin Boylan, MD

Mayo Clinic in Florida
Jacksonville, FL United States
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Michael Rivner, MD

Augusta University (Georgia Regents Medical Center)
Augusta, GA United States
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Nicholas Maragakis, MD

Johns Hopkins Hospital
Baltimore, MD United States
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Sabrina Paganoni, MD

Massachusetts General Hospital
Boston, MA United States
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Seward Rutkove, MD

Beth Israel Deaconess Medical Center
Boston, MA United States
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Stephen Goutman, MD

University of Michigan
Ann Arbor, MI United States
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Dale J Lange, MD

Hospital for Special Surgery
New York, NY United States
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Richard Bedlack, MD

Duke University Hospital
Durham, NC United States
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Zachary Simmons, MD

Penn State College of Medicine Milton S. Hershey Medical Center
Hershey, PA United States
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