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Quick Info
Status
This study has been completed
Phase
2
Trial Type
Double blind, Placebo controlled
Treatment Type
Orally available
Randomization
Unknown
Enrollment
60
Start Date
4/1/2013
Contact Information
    Contact information unknown.
Locations
United States, California
California Pacific Medical Center, San Francisco, CA, United States
United States, District of Columbia
Georgetown University Medical Center, Washington, DC, United States
United States, Michigan
Saint Mary's Health Care, Grand Rapids, MI, 49503, United States
United States, Minnesota
Hennepin County Medical Center, Minneapolis, MN, United States
United States, Nebraska
Neurology Associates, P.C., Lincoln, NE, United States
United States, Ohio
The Cleveland Clinic, Cleveland, OH, United States
United States, Oregon
Providence ALS Center, Portland, OR, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>50%
Months Since Onset
Number of months since first symptoms of ALS.
N/A
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Unknown
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Maybe
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Open Label
Unknown
Update Notes
No significant updates
3/27/2017
Recruitment Status Updated
6/21/2016
Recruitment status updated. Active, not recruiting.
2/20/2015
Recruitment status updated.
10/22/2014
No significant updates
7/31/2014
No significant updates.
5/20/2014
No significant updates.
4/9/2014
No significant updates.
4/4/2014
Recruitment status updated
1/24/2014
Contact information updated.
1/2/2014
Contact information updated
11/26/2013
No significant updates
9/3/2013
No significant updates
8/22/2013
No significant updates
8/16/2013
No significant updates
7/31/2013
No significant updates.
6/3/2013
No significant updates.
5/21/2013
No significant updates.
5/13/2013
New location added.
4/26/2013
Description updated.
4/19/2013
Protocoll updated.
4/5/2013
Enrollment criteria updated.
3/29/2013
Enrollment criteria added.
3/27/2013
Description updated.
3/26/2013
Protocol updated.
3/13/2013
Clinical trial added.
3/8/2013

Other Information

Purpose
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).
Eligibility
18+, all genders, no healthy volunteers, see protocol
Details
Nuedexta®, approved for the treatment of labile emotionality (pseudobulbar affect) 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.
Trial Protocol as Published on Clinicaltrials.gov
NCT01806857 (First Published: 3/5/2013)