- Researchers are seeking 60 people with amyotrophic lateral sclerosis (ALS) to participate in a phase 2 trial to test Nuedexta.
- The trial, which is being conducted at seven sites in the United States, is designed to evaluate whether Nuedexta has any effects on bulbar functions including speech, swallowing and saliva production.
- Nuedexta is approved by the U.S. Food and Drug Administration to treat pseudobulbar affect (PBA) — a neurological disorder in which episodes of laughing or crying occur out of proportion or unrelated to mood — in ALS.
Update (Jan. 28, 2014): This story has been updated with new contact information for study coordinator Cindy Rohde at Hennepin County Medical Center in Minneapolis.
The Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) is actively seeking people with amyotrophic lateral sclerosis (ALS) to participate in a phase 2 clinical trial designed to evaluate whether Nuedexta has any effects on bulbar functions including speech, swallowing and saliva function.
Nuedexta is composed of two drugs: the commonly used cough suppressant dextromethorphan hydrobromide and quinidine sulfate, which increases blood levels of dextromethorphan by interfering with its breakdown in the body.
Developed by Avanir Pharmaceuticals, Nuedexta was approved by the U.S. Food and Drug Administration (FDA) in October 2010 for the control of pseudobulbar affect (PBA) in ALS.
Although it is available by prescription for the treatment of PBA in ALS, Nuedexta is not approved to treat bulbar function in the disease and its effects on bulbar symptoms in ALS are unknown. MDA does not recommend anyone use Nuedexta to treat bulbar symptoms in ALS until its safety and efficacy have been proven in clinical trials.
About the study
Study investigators expect to enroll approximately 60 participants for the study, which is set to take place at seven sites across the United States.
Participants will be randomly assigned to one of two groups. Those in the first group will receive treatment with Nuedexta for 28 days, then a placebo for 28 days. Those in the second group will receive a placebo for 28 days, followed by treatment with Nuedexta for 28 days.
Participants must be age 18 or older; have a diagnosis of suspected, possible, probably or definite ALS according to El Escorial Criteria; and meet other study requirements.
To participate in the Nuedexta trial
For more details about the study, see:
Study sites are located at:
|California Pacific Medical Center
San Francisco, Calif.
Principal investigator: Jonathan Katz
Contact: Marguerite Engel at (415) 600-3758, or firstname.lastname@example.org
Contact: Dallas Forshew at (415) 600-3928, or email@example.com
|Neurology Associates, P.C.
Principal investigator: Gary Pattee
Contact: Becky Weber at (402) 483-5517, or firstname.lastname@example.org
|Georgetown University Medical Center
Principal investigator: Brent Harris
Principal investigator: Michael Sirdofsky
Contact: Connell Owings at (202) 444-2658, or email@example.com
|The Cleveland Clinic
Principal investigator: Erik Pioro
Contact: Nicole Berry at (216) 445-1741, or firstname.lastname@example.org
|Saint Mary's Health Care
Grand Rapids, Mich.
Principal investigator: Deborah Gelinas
Contact: Lynn Cherney at (616) 685-5091, or email@example.com
|Providence ALS Center
Principal investigator: Kimberly Goslin
Contact: Pamela Andrews at (503) 962-1171, or Pamela.firstname.lastname@example.org
Hennepin County Medical Center
Principal investigator: Gregg Meekins
Contact: Cindy Rohde at (612) 873-2607, or email@example.com
Contact: Diane Rauch at (612) 341-7918, or firstname.lastname@example.org
To participate, contact the site nearest you, or Angela S. Knox at the Massachusetts General Hospital Coordination Center: (617) 724-3314, or email@example.com.
About Clinical Trials
A clinical trial is a test, in humans, of an experimental treatment. Although it's possible that benefit may be derived from participating in a clinical trial, it's also possible that no benefit, or even harm, may occur.
MDA has no ability to influence who is chosen to participate in a clinical trial.
To learn more about clinical trials, see Being a Co-Adventurer. For a more refined list of ALS clinical trials, visit ClinicalTrials.gov, a registry of federally and privately supported clinical trials in the United States and around the world. Select the "Find Studies" tab, and follow the instructions to narrow down your search results.