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Withania somnifera for Lou Gehrig's Disease (NIALS Trial)

Phase 2
Waitlist Available
Led By Agessandro Abrahao, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 9 weeks

Summary

This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS).

Eligible Conditions
  • Lou Gehrig's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (safety)
Secondary study objectives
Change in RMT values
Change in SICI values
Change in recovery cycle
+1 more
Other study objectives
Change in serum IL-6 levels
Incident cases of ALSFRS-R score changes of 4 or more points

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium dosage Withania somniferaExperimental Treatment1 Intervention
272mg oral twice a day
Group II: High dosage Withania somniferaExperimental Treatment1 Intervention
544mg oral twice a day
Group III: PlaceboPlacebo Group1 Intervention
Matched capsules twice a day

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,780 Total Patients Enrolled
Agessandro Abrahao, MD, MScPrincipal InvestigatorSunnybrook Research Institute, University of Toronto
2 Previous Clinical Trials
17 Total Patients Enrolled
Lorne Zinman, MD, MScStudy DirectorSunnybrook Research Institute, University of Toronto
~19 spots leftby Nov 2025
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