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Abstract Details

Analysis of Amyotrophic Lateral Sclerosis (ALS) Clinical Trials Posted on www.clinicaltrials.gov from 1999-2022.
Neuromuscular and Clinical Neurophysiology (EMG)
P10 - Poster Session 10 (8:00 AM-9:00 AM)
10-011
ALS is a progressive neurodegenerative disease of the brain and spinal cord neurons with a typical lifespan of 3-5 years from symptom onset. Clinical trials have evolved over the past three decades as more awareness and research funding have been dedicated to understanding and treating ALS, partially due to the ALS Ice Bucket Challenge in 2014. A review of the evolution of study design and parameters over time provides insights into the future of clinical trials and is reflective of improvements in the science.
 To create a database of Amyotrophic Lateral Sclerosis (ALS) clinical trials on www.clinicaltrials.gov and analyze trends over the past three decades.

 “ALS” and “Amyotrophic Lateral Sclerosis” were searched on www.clinicaltrial.gov in August 2022. A database was created to capture information on trials: year posted, study type, primary endpoints, and inclusion criteria. 


The term ALS had 777 results and Amyotrophic Lateral Sclerosis had 891 results, for a total of 954 unique clinical trials from 1999 to 2022. Two hundred and seventy-three trials were removed due to non-ALS trials (other neurological disorders, drug name with ALS, or advanced life support) and 681 were analyzed. Thirty-four countries were represented with the United States (n=288, 43%), France (n=71, 11%),and Italy (n=28, 4.1%) having the highest number. The largest number of new trials posted in one year was in 2021 with 81. Forty-eight percent of studies are completed, and 146 (21%) are actively recruiting. Length of time to primary endpoint ranged between one day to ten years. 40% of studies did not specify ALS diagnostic criteria for eligibility and 4% required genetic testing.
Analyzing current and past trends of ALS clinical trials will help guide future trial designs in the hopes to optimize ALS outcomes and trials.
Authors/Disclosures
Aaron Simon Zelikovich, MD (Weill Cornell / NewYork-Presbyterian)
PRESENTER
Dr. Zelikovich has nothing to disclose.
Eric Anderson No disclosure on file
Michael Rubin, MD, FAAN (Weill Cornell Medicine / New York Presbyterian Hospital) Dr. Rubin has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for NeuroAlert. Dr. Rubin has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Merck Manual.
Jinsy Andrews, MD, FAAN (Columbia University Medical Center) Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wave Life Sciences. Dr. Andrews has received personal compensation in the range of $0-$499 for serving as a Consultant for Cytokinetics. Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Apellis . Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revalasio . Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AL-S Pharma. Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Quralis . Dr. Andrews has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Neurosense. Dr. Andrews has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Akava. The institution of Dr. Andrews has received research support from Amylyx. The institution of Dr. Andrews has received research support from Biogen . The institution of Dr. Andrews has received research support from Cytokinetics . The institution of Dr. Andrews has received research support from NIH . The institution of Dr. Andrews has received research support from Biohaven/Platform Trial. The institution of Dr. Andrews has received research support from Clene/Platform Trial . The institution of Dr. Andrews has received research support from Ra Pharma/Platform Trial . The institution of Dr. Andrews has received research support from Prilenia/Platform Trial . Dr. Andrews has received research support from ALS Association . Dr. Andrews has a non-compensated relationship as a Board of Trustee Member with ALS Association that is relevant to AAN interests or activities.