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Clinical Trial Nuedexta in Subjects With ALS

NCT01806857 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-03-24

Study results available
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Summary

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).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Nuedexta

Nuedexta PO (by mouth) for 28 ± 3 days

DRUG

Matching Placebo

matching placebo PO (by mouth) for 28 ± 3 days

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • State University of New York - Upstate Medical University

    collaborator OTHER

  • Center for Neurologic Study, La Jolla, California,

    lead OTHER

Principal Investigators

  • Richard A Smith, MD · Center for Neurologic Study (CNS)

  • Jeremy Shefner, MD, PhD · Barrow Neurological Institute

  • Merit E Cudkowicz, MD, MSc · Massachusetts General Hospital (MGH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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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 NCT01806857 on ClinicalTrials.gov