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

NCT06215755 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-15

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS.

Conditions

Interventions

DRUG

VRG50635

Part 1, no study drug will be administered. Part 2, the starting dose is 400 mg for 8 weeks (Treatment Period 1) and doses will be escalated to 600 mg for 8 weeks (Treatment Period 2) and 800 mg for 8 weeks (Treatment Period 3). Part 3, each participant will continue receiving treatment with the highest tolerated dose achieved in Part 2 for up to 40 weeks.

Sponsors & Collaborators

  • Verge Genomics

    lead INDUSTRY

Principal Investigators

  • Diego Cadavid, MD · Verge Genomics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-07-07
Completion
2025-07-07

Countries

  • Belgium
  • Canada
  • Finland
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215755 on ClinicalTrials.gov