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Clinical Trial of Ezogabine (Retigabine) in ALS Subjects

NCT02450552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-08-28

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ezogabine

Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Harvard University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Brian Wainger

    lead OTHER

Principal Investigators

  • Brian Wainger, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-01-31
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450552 on ClinicalTrials.gov