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Neurotherapeutics. 2017 Jul;14(3):762-772. doi: 10.1007/s13311-016-0508-5.

Enhanced Bulbar Function in Amyotrophic Lateral Sclerosis: The Nuedexta Treatment Trial.

Author information

1
Center for Neurologic Study, 7590 Fay Ave., Suite 517, La Jolla, CA, 92037, USA. cnsonline@ymail.com.
2
Cleveland Clinic, Department of Neurology, Mail Code S90, 9500 Euclid Ave., Cleveland, OH, 44195, USA.
3
Center for Neurologic Study, 7590 Fay Ave., Suite 517, La Jolla, CA, 92037, USA.
4
Georgetown University Hospital, Department of Neurology, Pasquerilla Healthcare Center, 7th Floor, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA.
5
Providence ALS Center, 5050 NE Hoyt St., #315, Portland, OR, 97123, USA.
6
Department of Neurology, University of Minnesota, 420 Delaware St. SE, Minneapolis, MN, 55455, USA.
7
Neurological Clinical Research Institute and Biostatistics Center, Massachusetts General Hospital, 15 Parkman Street, Boston, MA, 02114, USA.
8
Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA.
9
Department of Neurology, University of Florida College of Medicine, HSC P.O. Box 100236, Gainesville, FL, 32610-0236, USA.
10
Neurology Associates, 2631 S. 70th St., Lincoln, NE, 68506, USA.

Abstract

The goal of this randomized, blinded, crossover clinical trial was to determine whether Nuedexta (dextromethorphan and quinidine) enhanced speech, swallowing, and salivation in patients with ALS. Sixty patients with amyotrophic lateral sclerosis (ALS) received either Nuedexta or placebo for 28 to 30 days, followed by a 10 to 15-day washout period. Subsequently, patients were switched to the opposite treatment arm for the remaining days of the trial. The primary endpoint was a reduction in the self-report Center for Neurologic Study Bulbar Function Scale (CNS-BFS) score. The rater-administered ALS Functional Rating Scale Revised was the principal secondary endpoint. The CNS-BFS score improved with active treatment, decreasing from a mean of 59.3 in the placebo arm of the trial to 53.5 during the drug-treatment arm (p < 0.001). Each of the individual domains of bulbar function interrogated by the CNS-BFS responded to treatment with Nuedexta as follows: salivation: 15.8 versus 14.3 (p = 0.004); speech: 24.6 versus 22.2 (p = 0.003); swallowing: 18.9 versus 17.1 (p = 0.009). Similarly, the bulbar component of the ALS Functional Rating Scale Revised improved with active treatment (p = 0.003), although the drug did not affect the motor and respiratory components of this scale. This study is unique for several reasons. Firstly, it was driven by patient reports of improved speech and swallowing while taking Nuedexta for control of emotional lability. Secondly, the study was conducted over a short duration (70 days), and thirdly, a self-report scale was selected as the principle outcome measure. Considering the importance of bulbar functions, these results, if confirmed, point to an additional use of Nuedexta as an adjunct to the management of ALS.

KEYWORDS:

Amyotrophic lateral sclerosis; Nuedexta; bulbar function; clinical trial; dextromethorphan; self-report scale

PMID:
28070747
PMCID:
PMC5509619
DOI:
10.1007/s13311-016-0508-5
[Indexed for MEDLINE]
Free PMC Article

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