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Virus Therapy

VGL101 for Leukoencephalopathy

Phase 2

Recruiting

Research Sponsored by Vigil Neuroscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial tests a drug to help adults with ALSP, with infusions over a year to check safety and outcomes.

Who is the study for?

This trial is for adults with a specific brain condition called ALSP, confirmed by MRI and genetic testing showing a CSF1R gene mutation. Participants must have someone to report on their health status. Those with other neurological conditions that could confuse study results or pose significant risks are excluded.Check my eligibility

What is being tested?

The study tests VGL101's safety and its effect on disease progression in ALSP patients. It involves regular infusions of the drug every four weeks over one year, monitoring through imaging and biomarkers.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at the infusion site, changes in blood tests or vital signs, and any organ-specific issues due to the new medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

To evaluate the effects of VGL101 on biomarkers of disease progression in participants with ALSP

To evaluate the effects of VGL101 on biomarkers of target engagement in participants with ALSP

To evaluate the effects of VGL101 on in the ALSP severity score based on MRI in participants with ALSP

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: VGL101Experimental Treatment1 Intervention

Solution administered via Intravenous Infusion (IV)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vigil Neuroscience, Inc.Lead Sponsor

2 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Amyotrophic Lateral Sclerosis Research Study Groups: VGL101

Frequently Asked Questions

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

Has VGL101 been granted authorization by the Food and Drug Administration?

"VGL101 was assessed a safety score of 2 because it is in Phase 2 trials and has not yet been proven to be efficacious, though there are some preliminary data suggesting the drug's safety."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative. The information located on clinicaltrials.gov reports that this scientific experiment is still searching for participants, having been initially posted December 31st 2022 and most recently updated in December 22nd 2022. Fifteen individuals are needed between two different locations to take part in the trial."

Answered by AI

Are there currently any openings in this clinical trial?

"Affirmative. Clinicaltrials.gov has published that this research is actively enrolling volunteers, with the initial post dating to December 31st 2022 and the most recent update taking place on December 22nd 2022. 15 individuals need to be sourced from 2 different medical facilities for participation in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia

2022. "A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05677659.

All > White Matter Disease > Als