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Vgl101

Clinical trials are investigating Vgl101 in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a type of leukoencephalopathy. These studies are looking mainly at safety, tolerability, and early signs of benefit. The trial data here include adults with this rare condition.

Table of contents

Trials overview

The available clinical trial data show one interventional study of Vgl101 in adults with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).[1]

This study was designed to look at safety, tolerability, and early signs of benefit, which is called proof-of-concept.[1]

Study population and condition

The trial focused on people with ALSP, which is a rare form of leukoencephalopathy that affects the brain’s white matter.[1]

The source data identifies the study population as patients with this condition, but it does not list more detailed entry rules such as age ranges, disease stage, or other eligibility limits.[1]

Study design and phase

This was an interventional study, meaning the research team gave the study treatment to participants and then measured the results.[1]

The trial is listed as Phase 4 in the source data, and it is also described as a phase 2 safety, tolerability, and proof-of-concept study.[1]

The intervention was Vgl101 given as a 40 mg/kg intravenous infusion, according to the trial record.[1]

What the trial measured

The main outcome was safety and tolerability, measured by the number and type of adverse events, serious adverse events, and treatment stops because of side effects.[1]

The study also checked safety laboratory tests, immunogenicity tests, vital signs, electrocardiograms, and the Columbia-Suicide Severity Rating Scale (C-SSRS).[1]

These tests help researchers see whether the treatment causes medical problems, affects the heart, triggers an immune response, or raises concerns about mood or safety.[1]

Trial status and enrollment

The study status is listed as Completed.[1]

The enrollment was 18 participants, which means 18 people joined the study.[1]

Patient-friendly terms

Adverse event means any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.[1]

Serious adverse event means a severe problem that can be life-threatening or cause major harm.[1]

Immunogenicity means the body may make an immune response against the treatment.[1]

Electrocardiogram is a test that records the heart’s electrical activity.[1]

C-SSRS is a questionnaire used to check for suicidal thoughts or behavior.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05677659 Phase 4 Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) Completed 18

FAQ

  • What condition is Vgl101 being studied for? The trial is studying Vgl101 in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). This is a rare brain disease that affects the white matter.
  • Who can take part in the study? The trial includes patients with ALSP. The source data does not list more detailed entry rules, such as age limits or other health requirements.
  • What is the main goal of the trial? The main goal is to check safety and tolerability. That means the study looks at how well people can receive Vgl101 and what side effects or other safety issues may happen.
  • What phase is the Vgl101 trial? The trial is listed as Phase 4 in the source data. It is also described as a phase 2 safety, tolerability, and proof-of-concept study.
  • What does proof-of-concept mean? Proof-of-concept means the study is also looking for early signs that the treatment may help. It is not the same as proving long-term benefit.

Ongoing Clinical Trials on Vgl101

  • Study on the Safety and Tolerability of VGL101 for Adults with Adult-Onset Leukoencephalopathy

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany The Netherlands

Glossary

  • Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP): A rare disease that affects the brain’s white matter. It can cause problems with thinking, movement, and other brain functions.
  • Leukoencephalopathy: A group of disorders that damage the white matter of the brain. White matter helps brain signals move quickly and smoothly.
  • Phase 4: A later stage of clinical research. It usually studies a treatment in a more real-world setting, often after earlier testing.
  • Proof-of-concept: Early evidence that a treatment may work for the condition being studied.
  • Safety: How well a treatment can be given without causing unacceptable harm.
  • Tolerability: How well patients can handle a treatment and its effects.
  • Adverse event: Any unwanted medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: An unwanted medical problem that is severe, life-threatening, or causes major harm.
  • Immunogenicity: Whether the body makes an immune response against the treatment.
  • Electrocardiogram: A test that records the heart’s electrical activity.
  • Columbia-Suicide Severity Rating Scale (C-SSRS): A questionnaire used to check for suicidal thoughts or behavior.

References