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

Phase 2
Recruiting
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
Awards & highlights

NIALS Trial 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

NIALS Trial 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

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

NIALS 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
656 Previous Clinical Trials
1,550,547 Total Patients Enrolled
Agessandro Abrahao, MD, MScPrincipal InvestigatorSunnybrook Research Institute, University of Toronto
2 Previous Clinical Trials
18 Total Patients Enrolled
Lorne Zinman, MD, MScStudy DirectorSunnybrook Research Institute, University of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
NF-κB Inhibition in Amyotrophic Lateral Sclerosis
2021. "NF-κB Inhibition in Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05031351.
All > Lou Gehrigs Disease > Als
~21 spots leftby Apr 2025
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