Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
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.
Unexpectedly, Nuedexta®, approved for the treatment of labile emotionality that occurs in
association with ALS and other neurological disorders, has been observed to improve bulbar
function, primarily speech and swallowing, in a number of neurological disorders, including
ALS. The basis for this is conjectural but likely due to a direct effect of the drug on
motor neurons in the part of the brain that controls speech and swallowing. The same part of
the brain appears to modulate the expression of emotions and interestingly the site of
action of the drug is the same as a site that has been implicated in a juvenile form of ALS.
This is a multicenter, randomized double-blind, placebo controlled, cross over study
evaluating the palliative effect of Nuedexta® on bulbar dysfunction. It is expected that
approximately 60 ALS patients from 7 clinical centers in the US will be enrolled.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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