NCT05031351

NF-κB Inhibition in Amyotrophic Lateral Sclerosis

Nuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

There will be up to 75 participants randomized 1:1:1 to receive either high dosage Withania somnifera extract (1088 mg daily), medium dosage Withania somnifera extract (544 mg daily) or matching placebo. The study will consist of a Screening Period, Randomization visit, Baseline visit, and Follow-up visits. The treatment period will be 8 weeks and a final follow up call will occur at Week 9.

Conditions

• ALS

Interventions

Type	Name	Description
DRUG	Withania somnifera	Nuclear Factor Kappa Beta Inhibitor
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-07-01
• Completion: 2022-09-01
• First posted: 2021-09-01
• Last updated: 2022-06-06

Locations

1 site across 1 country: Canada