Safety and Efficacy of AVP-923 in PBA (Pseudobulbar Affect) Patients with ALS

Project Summary

This clinical study is actively recruiting and enrolling people with amyotrophic lateral sclerosis (ALS) who have pseudobulbar affect, a neurologic condition characterized by episodes of uncontrollable laughing and/or crying. People with pseudobulbar affect are being sought for approximately 30 U.S. study sites testing the efficacy and safety of a targeted investigational treatment known as Zenvia™ or AVP-923.

Study Sites

Arizona
St. Joseph's Hospital and Medical Center     
Phoenix, Arizona 85013 
Contact: Mia Porter    
602-406-5858    
mia.prteool@chw.edu     
Principal Investigator: Timothy Vollmer, M.D.  

Neuromuscular Research Center    
Scottsdale, Arizona 85258 
Contact: Ricardo Bien-Willner    
480-314-1026    
rwillner@azneuromuscular.org     
Principal Investigator: K. Sivakumar, M.D.             

California
UCLA School of Medicine 
Los Angeles, California 90095 
Contact: Rebecca Alvarez    
310-794-2557    
ralvarez@mednet.ucla.edu     
Principal Investigator: Michael Graves, M.D.       

Center for Neurologic Study    
La Jolla, California 92103 
Contact: Luci Barbie    
858-455-5463   
cns@cts.com     
Principal Investigator: Jonathan Licht, M.D.     

The ALS Center at UCSF
San Francisco, California 94117 
Contact: Claudia Villerme    
415-476-2662    
claudia.villerme@ucsf.edu     
Principal Investigator: Catherine Lomen-Hoerth, M.D.   

South Coast Clinical Trials, Inc.
Anaheim, California 92804
Contact: Rachel Chohlidakis, MD 
714-484-4904                              
rachel@southcoastclinicaltrials.com
Principal Investigator: Jason Kellogg, M.D.

Colorado
University of Colorado at Denver & Health Science Center
Aurora, Colorado 80045 
Contact: John Cumming    
415-476-7581    
john.cumming@uchsc.edu   
Principal Investigator: Bjorn Oskarsson, M.D.              

Florida
Mayo Clinic    
Jacksonville, Florida 32224 
Contact: Karen Overstreet    
904-953-8946    
overstreet.karen@mayo.edu     
Principal Investigator: Kevin Boylan, M.D.  

Neuroscience Center  
Ft. Lauderdale, Florida 33334 
Contact: Vivian Tastel    
954-738-1697    
vtastel@researchneurology.org     
Principal Investigator: Brian Steingo, M.D.             

Suncoast Neuroscience Associates  
St. Petersburg, Florida 33701 
Contact: Michele Richardson    
727-824-7189    
mrichardson@suncoastmed.com     
Principal Investigator: Alberto Vasquez, M.D.  

University of Miami 
Miami, Florida 33136 
Contact: Donald Koggan    
305-243-7424    
dkoggan@med.miami.edu     
Principal Investigator: Ashok Verma, MD             

Georgia
The ALS Center at Emory University    
Atlanta, Georgia 30322 
Contact: Meraida Polak    
404-778-3807    
mpolak@emory.edu     
Principal Investigator: Jonathan Glass, M.D.             

Illinois
Consultants in Neurology  
Northbrook, Illinois 60062 
Contact: Andrea Corsino    
847-509-0270    
research@cinltd.com 
Principal Investigator: Daniel R. Wynn, M.D. 

Northwestern University     
Chicago, Illinois 60611 
Contact: Pat Casey    
312-695-0774    
pcasey1@nmff.org     
Principal Investigator: Robert Sufit, M.D.             

Maryland
The John Hopkins University
Baltimore, Maryland 21287 
Contact: Lora Clawson   
410-614-7178    
lclawson@jhmi.edu     
Principal Investigator: Andrea Corse, M.D.             

Massachusetts
Baystate Medical Center  
Springfield, Massachusetts 01199 
Contact: Elaine Reich    
413-794-5856    
elaine.reich@bhs.org     
Principal Investigator: Carmel Armon, M.D.             

Michigan
University of Michigan
Ann Arbor, Michigan 48109 
Contact: Kathleen Ryan    
734-936-2920    
kathr@med.umich.edu     
Principal Investigator: Ann Little, M.D.             

Missouri
St. Louis University - Neuromuscular Clinic 
St. Louis, Missouri 63110 
Contact: Tony Cook  
314-977-6172  
tcook7@slu.edu    
Principal Investigator: Ghazala Hayat, M.D.             

Montana
Advanced Neurology Specialists 
Great Falls, Montana 59405 
Contact: Veronica Schaefer    
406-727-3720    
ansresearch@yahoo.com      
Principal Investigator: Dennis Dietrich, M.D.             

Nebraska
Neurology Associates   
Lincoln, Nebraska 68506 
Contact: Kathie Allstot    
402-483-1728    
kallstotnapc@yahoo.com     
Principal Investigator: Gary Pattee, M.D.             

New York
Mount Sinai Medical Center 
New York, New York 10029 
Contact: Gregory Seidel    
212-241-8389    
gregory.seidel@mssm.edu     
Principal Investigator: Dale Lange, M.D.  

Neurological Institute - Columbia Presbyterian Center
New York, New York 10032 
Contact: Kate Bednarz    
212-305-2027    
keb2114@columbia.edu     
Principal Investigator: Hiroshi Mitsumoto, M.D.

Jacobs Neurological Institute 
Buffalo, New York 14203 
Contact: Kara Patrick    
716-859-7510    
kpatrick@kaleidahealth.org     
Principal Investigator: Bianca Weinstock-Guttman, M.D.  

Upstate Clinical Research
Albany, New York 12205 
Contact: Suzanne Alterman    
518-533-1546    
salterman@upstateneurology.com     
Principal Investigator: James Wymer, M.D.             

North Carolina
Duke University Medical Center
Durham, North Carolina 27710 
Contact: Joan Jones    
919-668-2839    
jones0018@mc.duke.edu     
Principal Investigator: Richard Bedlack, M.D.

Carolinas Medical Center 
Charlotte, North Carolina 28207 
Contact: Lien Ngo    
704-446-6028    
lien.ngo@carolinashealthcare.org     
Principal Investigator: Elena Bravver, M.D.             

Ohio
Department of Neurology - The Cleveland Clinic Foundation
Cleveland, Ohio 44195 
Contact: Ruthie Kolb    
216-445-1741    
kolbr@ccf.org     
Principal Investigator: Erik Pioro, M.D.

Ohio State University
Columbus, Ohio 43210 
Contact: Sharon Chelnik    
614-293-4973    
sharon.chelnik@osumc.edu     
Principal Investigator: Steven Nash, M.D.             

Pennsylvania
The ALS Center - Penn Neurological Institute - The University of Pennsylvania
Philadelphia, Pennsylvania19107 
Contact: Laura Klenke-Borgmann    
205-829-5041    
laura.klenke@uphs.upenn.edu     
Principal Investigator: Leo McCluskey, M.D.

Drexel University - Department of Neurology
Philadelphia, Pennsylvania 19107 
Contact: Christine Barr    
215-762-5186    
cbarr@drexelmed.edu     
Principal Investigator: Terry Heiman-Patterson, M.D.             

Tennessee
Vanderbilt University
Nashville, Tennessee 37232 
Contact: Kay Artibee    
615-936-8102    
kay.j.artibee@vanderbilt.com     
Principal Investigator: Peter Donofrio, M.D.              

Texas
Department of Neuropsychiatry - Texas Tech University
Lubbock, Texas 79430 
806-743-2820         
Principal Investigator: Randolph Schiffer, M.D.  

The Methodist Hospital - Baylor College of Medicine
Houston, Texas 77030
Contact: Angela Lavespere    
713-441-3420    
aslavespere@tmhs.org     
Principal Investigator: Ericka Simpson, M.D.             

Vermont
University of Vermont 
Burlington, Vermont  05405 
Contact: Shannon Lenox    
802-656-3876    
shannon.lenox@uvm.edu     
Principal Investigator: Rup Tandan, M.D