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Virus Therapy

VGL101 for Leukoencephalopathy

Phase 2
Waitlist Available
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 weeks 52, 76, 100, 124, and 148
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing iluzanebart, a medication given through infusions, in adults with a specific genetic mutation causing ALSP, a rare brain disease. The goal is to see if the medication is safe and can slow down the disease by looking at brain scans and other health markers. Participants will receive the treatment regularly for a year, with an option to continue for additional years.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~weeks 52, 76, 100, 124, and 148
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 52, 76, 100, 124, and 148 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Core Study Adverse Events
Long-Term Extension Adverse Events
Secondary study objectives
To evaluate the effects of iluzanebart on biomarkers of disease progression in participants with ALSP in the Core Study
To evaluate the effects of iluzanebart on biomarkers of target engagement in participants with ALSP in the Core Study
To evaluate the effects of iluzanebart on the ALSP on biomarkers of disease progression and clinical outcomes in patients with ALSP in the Core Study
+1 more

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: VGL101Experimental Treatment1 Intervention
Solution administered via Intravenous Infusion (IV)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for ALS include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol (PB-TURSO). Riluzole works by inhibiting glutamate release, thereby reducing excitotoxicity, which is believed to contribute to motor neuron death. Edaravone acts as an antioxidant, reducing oxidative stress and slowing functional decline. PB-TURSO combines two drugs that reduce neuronal cell death through different mechanisms, including mitochondrial and endoplasmic reticulum stress reduction. These treatments are crucial for ALS patients as they target various pathways involved in disease progression, offering a multifaceted approach to slowing the decline in motor function. Similar to VGL101, which targets the CSF1R gene mutation pathology in ALSP, these treatments aim to modify disease progression rather than just alleviating symptoms.

Find a Location

Who is running the clinical trial?

Vigil Neuroscience, Inc.Lead Sponsor
2 Previous Clinical Trials
168 Total Patients Enrolled

Media Library

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