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VRG50635 for Amyotrophic Lateral Sclerosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 80 weeks

Awards & highlights

Study Summary

This trial is focused on testing the safety and tolerability of a drug called VRG50635 in people with ALS.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 80 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 80 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 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

Number of Participants with Clinical Laboratory Evaluation Abnormalities

Number of Participants with Electrocardiogram (ECG) Abnormalities

Number of Participants with Neurological Examination Abnormalities

+3 more

Secondary outcome measures

Area Under the Concentration-time Curve (AUC)

Change from Baseline in Plasma Levels of Neurofilament Light Chain (NfL) as Measured by Immunoassay

Change in Harmonized ALS Functional Rating Scale-Revised (ALS-FRS-R) Score

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: VRG50635Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Verge GenomicsLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to participate in this medical study?

"Individuals aged 18 to 74, diagnosed with amyotrophic lateral sclerosis (ALS), are eligible for participation in this clinical trial. The study aims to enroll a total of 50 participants."

Answered by AI

What is the current number of participants involved in this research trial?

"Indeed, the information available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible candidates. The study was initially posted on January 15th, 2024 and has been recently updated on January 10th, 2024. A total of 50 participants will be enrolled at a single designated site."

Answered by AI

Is this research study currently accepting new participants?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is actively enlisting participants. The trial was originally posted on January 15th, 2024 and underwent its most recent update on January 10th, 2024. The study aims to recruit a total of 50 individuals from one designated location."

Answered by AI

Can individuals who are below the age of 20 participate in this medical study?

"To be eligible for participation in this trial, patients must fall within the age range of 18 to 74 years. There are a total of 38 trials available specifically tailored for patients below the age of 18, while there are 385 trials targeted towards individuals over the age of 65."

Answered by AI

Has the VRG50635 compound received approval from the FDA?

"Given that this is a Phase 1 trial, the safety rating for VRG50635 is estimated to be 1. This indicates limited available data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of VRG50635 in Participants With Amyotrophic Lateral Sclerosis (ALS)

2024. "A Study of VRG50635 in Participants With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215755.

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