An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS)
Study Purpose:
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
Not enrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Richard Bedlack, MD, PhD Duke University
Clinicaltrials.gov ID (11 digit #):
NCT04499963Neals Affiliated?
NoCoordinating Center Contact Information
Duke University Medical CenterLisa Harrison, RN / .(JavaScript must be enabled to view this email address) / 919-613-2681
.(JavaScript must be enabled to view this email address) Durham, North Carolina 27705 United States
Full Study Summary:
This will be a 6-month, widely inclusive, virtual, single-center, open-label pilot trial utilizing a historical control group. Following informed consent and screening, participants with ALS will take Theracurmin 1 capsule (90mg) twice daily for 6-months. Treatment with the Theracurmin and all study outcome measures and labs are being performed exclusively for research purposes. Collected data includes saliva and stool microbiome sampling, adverse events, concomitant medications, weight and height, Theracurmin treatment evaluations, and Thrive Questionnaires. Participants will be asked to register on the website Patientslikeme.
Study Sponsor:
Richard Bedlack, M.D., Ph.D.Participant Duration:
6 months