Withania somnifera for Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sunnybrook Health Sciences Centre, Toronto, Canada
Lateral Sclerosis+3 More
Withania somnifera - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

NF-κB Inhibition in Amyotrophic Lateral Sclerosis

See full description

Eligible Conditions

  • Lateral Sclerosis
  • Amyotrophic Lateral Sclerosis (ALS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lateral Sclerosis

Study Objectives

This trial is evaluating whether Withania somnifera will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Lateral Sclerosis. Measurement will happen over the course of Baseline to 8 weeks.

Baseline to 8 weeks
Change in Electrotonus
Change in RMT values
Change in SICI values
Change in recovery cycle
Change in serum IL-6 levels
Change in strength duration time constant
Baseline to 9 weeks
Incident cases of ALSFRS-R score changes of 4 or more points
Week 9
Incidence of adverse events (safety)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lateral Sclerosis

Trial Design

3 Treatment Groups

High dosage Withania somnifera
1 of 3
Medium dosage Withania somnifera
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 75 total participants across 3 different treatment groups

This trial involves 3 different treatments. Withania Somnifera is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

High dosage Withania somnifera
Drug
544mg oral twice a day
Medium dosage Withania somnifera
Drug
272mg oral twice a day
Placebo
Drug
Matched capsules twice a day

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 9 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 9 weeks for reporting.

Closest Location

Sunnybrook Health Sciences Centre - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The disease will last no longer than 36 months from the time of the screening visit. show original
If you are 18 years or older, you are legally allowed to vote in the United States. show original
, then edaravone may be continued during the trial If you have been taking edaravone on a stable dose for at least one cycle before the Screening Visit, you may continue taking edaravone during the trial. show original
will be allowed This means that people using BiPAP machines will only be allowed to use them for up to 12 hours per day. show original
Capable of providing informed consent and complying with study procedures
, discontinue riluzole for at least 10 days prior to Screening Visit If you are taking riluzole and have been on a stable dose for at least 30 days, discontinue the drug for at least 10 days before your screening visit. show original
The person has been diagnosed with amyotrophic lateral sclerosis (ALS) based on laboratory results and clinical symptoms. show original
: Patients who were able to swallow a capsule at Baseline Visit were more likely to be able to swallow a capsule at all of the study visits. show original
or Spanish is required You need to be fluent in English, French, or Spanish in order to do this job. show original

Patient Q&A Section

What is amyotrophic lateral sclerosis?

"Despite a limited clinical experience with ALS, our study suggests that the clinical features of ALS are similar to those of Parkinson's and may even be characterized by a Parkinsonian phenotype. As the clinical features differ depending on whether patients present or develop the disease while still in their 40s versus the 60s, new classification systems may have to be devised." - Anonymous Online Contributor

Unverified Answer

Can amyotrophic lateral sclerosis be cured?

"The main goal of research in this field is to develop therapies which will halt the course of the disease and hopefully cure it. The only therapies currently being used to stop the progression of the disease are medications which reduce the effects on nerves of the motor system. Studies using the mouse model show that it is possible to stop or slow down the breakdown of the motor neurons of the central nervous system. Although a cure for amyotrophic lateral sclerosis (ALS) is still elusive, these findings are a great improvement on the current situation and will lead to further research." - Anonymous Online Contributor

Unverified Answer

What causes amyotrophic lateral sclerosis?

"The mechanism of causation of amyotrophic lateral sclerosis remains unknown. Autoimmunity probably plays a major role. The only conclusive evidence is that antibodies to the nicotinic receptor are found specifically in some patients with ALS. Whether viral agents, immune-complex deposition or a rare genetic condition causes amyotrophic lateral sclerosis remains unknown. But it is likely that a combination of factors causes the disorder." - Anonymous Online Contributor

Unverified Answer

What are common treatments for amyotrophic lateral sclerosis?

"Most treatments are supportive, depending on the cause or causes of the disease, stage, age and lifestyle of the person. Many people experience significant improvement in quality of life and quality of life of people with ALS improves as their disease progresses and, ultimately, the person dies.\n" - Anonymous Online Contributor

Unverified Answer

How many people get amyotrophic lateral sclerosis a year in the United States?

"An estimated 100,000 diagnosed cases of amyotrophic lateral sclerosis (ALS) will be diagnosed by the year 2020 in the United States. By year 2017 an estimated 50,000 new cases will have happened per year. This has resulted in a decline of about 35% in the incidence of ALS in the United States in the 20th century." - Anonymous Online Contributor

Unverified Answer

What are the signs of amyotrophic lateral sclerosis?

"Decreased arm muscle volume, finger claw hands, bulbar symptoms, and spasticity and clonus are signs of ALS. The lack of limb muscle atrophy may be a clue to the possibility of an underlying neurological disorder in ALS." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating amyotrophic lateral sclerosis?

"The ALS/mRS classification and a recent genetic association study have led to the identification of two genes, UBQLN1 (alias C9orf72) and SOD1 (alias ALS2) with a strong association with the disease. These genes could be candidate drug targets in SOD1 deficient mouse models. However, the most recent candidate gene, TDP-43, has not been identified within the confines of the most commonly used mouse models for SOD1." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of amyotrophic lateral sclerosis?

"Data from a recent study suggest that the presence of autoimmune polyantibodies is unlikely to be the sole trigger for most forms of ALS and that the pathogenesis is likely multi-factorial. The role of viral infection and exposure to metals such as arsenic, lead and inhalants in ALS deserves further investigation." - Anonymous Online Contributor

Unverified Answer

Has withania somnifera proven to be more effective than a placebo?

"There was no significant difference among the mean values of the two groups at follow up period (mean = 4.5 and 4.5, respectively). Neither the overall improvement and relapse frequency at week 6 had a significant difference between the two groups. No side effect was reported in any of the groups. No toxicity was reported in any of the groups." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of withania somnifera?

"Withania somnifera exerts its toxicity by a range of mechanisms. Withania somnifera at various doses in rats induced hepato- and kidney-damage of different severity, with the most severe damage being observed at the higher doses." - Anonymous Online Contributor

Unverified Answer

Does withania somnifera improve quality of life for those with amyotrophic lateral sclerosis?

"WS treatment has beneficial health effects for those with ALS. There seem to be positive associations between withWS therapy and improvements in HRQoL. Whether this translates to meaningful improvements in quality of life for people with ALS remains to be determined." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets amyotrophic lateral sclerosis?

"These data suggest that the life expectancy for persons with a diagnosis of ALS remains low. In addition, persons with the same diagnosis of ALS are not only at risk of dying young, they may be at increased risk of dying shortly after onset of symptoms, perhaps reflecting a more rapid rate of disease progression." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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