Treatment for Lou Gehrig's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
VA North Texas Health Care System, Dallas, TXLou Gehrig's Disease
Eligibility
21 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating whether giving patients with ALS antioxidants could help slow or stop the progression of the disease. The original trial showed some benefits, so they are expanding it to include higher doses of antioxidants.

Eligible Conditions
  • Lou Gehrig's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Change in serum CK level from baseline to 12 months
Frequency of serious adverse events and adverse events.
Measurement of functional decline in ALS
Measurement of serum NfL
Survival analysis

Trial Safety

Safety Progress

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

Trial Design

0 Treatment Group

60 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,821 Total Patients Enrolled
Olaf Stuve, M.D., Ph.D.Principal InvestigatorDallas VA Medical Center
1 Previous Clinical Trials
9 Total Patients Enrolled

Eligibility Criteria

Age 21 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have ALS and take riluzole medication, you need to be on a steady dose for at least 30 days before the study.
References

Frequently Asked Questions

Could I be a candidate for this experiment?

"The ideal candidate for this study would be someone with amyotrophic lateral sclerosis that falls in the age range of 21 to 80. A total of 60 patients are needed." - Anonymous Online Contributor

Unverified Answer

Has this method been federally sanctioned?

"This is a Phase 2 trial, which means that while there is some data supporting safety, there is none yet to suggest efficacy. Therefore, our team at Power has estimated the safety of this treatment to be a 2." - Anonymous Online Contributor

Unverified Answer

Are patients who are 45 years or older able to enroll in this research project?

"The target age group for this clinical trial are adults aged 21 to 80 years old." - Anonymous Online Contributor

Unverified Answer

How many subjects are included in this trial?

"The trial is currently underway, with the most recent update to the clinicaltrials.gov page occurring on March 25th, 2022. This study seeks 60 participants from a single site." - Anonymous Online Contributor

Unverified Answer

Are researchers looking for more test subjects at this time?

"The clinicaltrials.gov website has the most up-to-date information on this matter, and it does show that the study is still recruiting patients. This particular trial was first posted on April 1st, 2022 and was last edited on March 25th, of the same year. They are looking for a total of 60 individuals who meet the requirements and are willing to participate in this experiment from one location." - 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.