The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
Study Purpose:
The purpose of this study is to determine whether Nuedexta® improves speech, swallowing and saliva control in subjects with ALSDisease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
ClosedPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)Richard A. Smith, MD (Center for Neurologic Study, La Jolla, CA)
Clinicaltrials.gov ID (11 digit #):
NCT01806857Neals Affiliated?
YesCoordinating Center Contact Information
Massachusetts General HospitalBrenda Thornell / .(JavaScript must be enabled to view this email address) / 617-643-3102
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Boston, Massachusetts 02114 United States
Full Study Summary:
Muscle weakness, the cardinal feature of ALS, leads to progressive loss of motor function affecting the limbs, tongue, respiratory and pharyngeal muscles. Symptomatic treatments such as the placement of a feeding tube can compensate for the inability to swallow. Riluzole, the only approved treatment for ALS, may slow disease progression but no treatment is curative and none have improved function. Since the effect of Nuedexta® on speech and swallowing has not been rigorously evaluated, a clinical trial has been designed to scientifically determine the effect of Nuedexta® on bulbar functions (speech, swallowing and salivation).Approximately 60 eligible subjects with ALS will be recruited from multiple centers in the US. Subjects will be treated for 28 days (±3 days) with either Nuedexta® or placebo. A 10-15 day washout period will then occur. After the washout period, subjects will be crossed-over to the other treatment arm for an additional 28 days (± 3 days) of treatment. A follow-up telephone call will occur approximately 28 days after completion of the study.