Evidence map›Paper›PMID 28070747›Full record

Trial reportNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2017

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

Richard Smith, Erik Pioro, Kathleen Myers, Michael Sirdofsky, Kimberly Goslin, Gregg Meekins, Hong Yu, James Wymer, Merit Cudkowicz, Eric A Macklin and 2 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 56 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Combination Pharmacology for ALS: A Mechanistic Rationale.International journal of molecular sciences · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Richard SmithCenter for Neurologic Study, 7590 Fay Ave., Suite 517, La Jolla, CA, 92037, USA. cnsonline@ymail.com.ORCID http://orcid.org/0000-0003-4200-9268
Erik PioroCleveland Clinic, Department of Neurology, Mail Code S90, 9500 Euclid Ave., Cleveland, OH, 44195, USA.
Kathleen MyersCenter for Neurologic Study, 7590 Fay Ave., Suite 517, La Jolla, CA, 92037, USA.
Michael SirdofskyGeorgetown University Hospital, Department of Neurology, Pasquerilla Healthcare Center, 7th Floor, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA.
Kimberly GoslinProvidence ALS Center, 5050 NE Hoyt St., #315, Portland, OR, 97123, USA.
Gregg MeekinsDepartment of Neurology, University of Minnesota, 420 Delaware St. SE, Minneapolis, MN, 55455, USA.
Hong YuNeurological Clinical Research Institute and Biostatistics Center, Massachusetts General Hospital, 15 Parkman Street, Boston, MA, 02114, USA.
James WymerDepartment of Neurology, University of Florida College of Medicine, HSC P.O. Box 100236, Gainesville, FL, 32610-0236, USA.
Merit CudkowiczNeurological Clinical Research Institute and Biostatistics Center, Massachusetts General Hospital, 15 Parkman Street, Boston, MA, 02114, USA.
Eric A MacklinNeurological Clinical Research Institute and Biostatistics Center, Massachusetts General Hospital, 15 Parkman Street, Boston, MA, 02114, USA.
David SchoenfeldNeurological Clinical Research Institute and Biostatistics Center, Massachusetts General Hospital, 15 Parkman Street, Boston, MA, 02114, USA.
Gary PatteeNeurology Associates, 2631 S. 70th St., Lincoln, NE, 68506, USA.
Harvard University · USCenter for Neurologic Study · USCleveland Clinic · USGeorgetown University · USProvidence Center · USUniversity of Florida · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdultAgedAmyotrophic Lateral SclerosisCross-Over StudiesDextromethorphanDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedQuinidineDextromethorphandextromethorphan - quinidine combinationDrug CombinationsQuinidineAmyotrophic lateral sclerosisbulbar functionclinical trialdextromethorphanNuedextaself-report scale

Identifiers

PMID28070747
PMCPMC5509619
OpenAlexW2568175576

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.