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VRG50635 for ALS

Phase 1
Recruiting
Research Sponsored by Verge Genomics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have either sporadic amyotrophic lateral sclerosis (sALS) or familial amyotrophic lateral sclerosis (fALS)
Have a diagnosis of ALS according to the Gold Coast Diagnostic Criteria
Must not have
Have a history of unstable or severe cardiac, pulmonary, neurological, oncological, hepatic, or renal disease or another medically significant illness other than ALS precluding their safe participation in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called VRG50635 to see if it is safe for people with ALS, a disease that affects nerve cells. The main goal is to check if patients can tolerate the drug without serious side effects.

Who is the study for?
This trial is for people with ALS who meet the Gold Coast Diagnostic Criteria, have either sporadic or familial ALS, a certain risk profile score, can swallow safely, and have specific breathing capacity and body weight measurements. It's not for those with severe psychiatric issues or other medical conditions that could affect study results.
What is being tested?
The study tests VRG50635's safety and tolerability in ALS patients. The main goal is to see how well participants handle the drug and what effects it has on their condition over time.
What are the potential side effects?
While specific side effects of VRG50635 are not listed here, common concerns in trials like this include reactions at the drug intake site, gastrointestinal issues, fatigue, headaches, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have ALS, either sporadic or inherited from my family.
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I have been diagnosed with ALS.
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I weigh at least 45 kg and my BMI is 18 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe health issues that would make it unsafe for me to join this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VRG50635Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VRG50635
2024
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Verge GenomicsLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
~30 spots leftby Jun 2026
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