What side effects are associated with this type of intervention?

The investigational drug ABBV-CLS-7262 for Vanishing White Matter Disease is still under study, so specific side effects are not fully known. However, common side effects for similar investigational treatments in neurological conditions often include fatigue, headaches, nausea, and potential changes in blood test results. Regular monitoring through medical assessments and blood tests is essential to manage and identify any adverse effects early.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Vanishing White Matter Disease (VWMD). ABBV-CLS-7262 is an investigational drug being studied for this condition, indicating a lack of established therapies. VWMD is a rare and progressive genetic disorder, and treatment options are generally supportive and symptomatic rather than curative. Research is ongoing to find effective therapies for this challenging disease.

What other types of research exist?

Currently, there are no specific novel alternatives to ABBV-CLS-7262 mentioned for Vanishing White Matter Disease patients in the provided context. Patients should consult with their healthcare provider for the most up-to-date treatment options and ongoing clinical trials.

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ABBV-CLS-7262 for Vanishing White Matter Disease

Q: What is the mechanism of action of this treatment?

ABBV-CLS-7262 is an investigational drug being studied for its potential to treat Vanishing White Matter Disease (VWMD), a condition characterized by the progressive loss of white matter in the brain. While specific details about ABBV-CLS-7262's mechanism of action are not provided, treatments for VWMD generally aim to stabilize or repair the myelin sheath, reduce inflammation, and protect neural cells from further damage. These mechanisms are crucial for VWMD patients as they help slow disease progression, preserve neurological function, and improve quality of life. By targeting the underlying causes of white matter degeneration, these treatments offer hope for managing a currently incurable and debilitating disease.

Phase 1 & 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately week 100

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ABBV-CLS-7262 in adults and children aged 6 years or older who have Vanishing White Matter disease. The study will last for almost two years and will involve frequent medical check-ups to see if the drug helps improve their condition.

Who is the study for?

Adults diagnosed with Vanishing White Matter disease, confirmed by a physician and MRI, who have a caregiver to assist them. Participants must be able to consent or have someone who can legally do so on their behalf. They should not have changed VWM medications in the last 4 weeks or received other investigational treatments recently. Adequate contraception is required for sexually active participants.

What is being tested?

The trial tests ABBV-CLS-7262's safety and how the body processes it over a period of 96 weeks in patients with Vanishing White Matter disease. It's an open-label study, meaning everyone knows they're getting the drug, without any comparison group.

What are the potential side effects?

Potential side effects are monitored through regular medical assessments and blood tests but are not specified here as this is an early phase trial investigating safety and tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately week 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately week 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately week 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration-Time Curve (AUC0-24h) of Fosigotifator

Plasma Concentration of Fosigotifator

Terminal Elimination Half-Life (t1/2) of Fosigotifator

+2 more

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events

Number of Participants with Change in Clinical Laboratory Tests

Number of Participants with Change in ECG

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Fosigotifator - Cohort 3Experimental Treatment1 Intervention

Cohort 3: VWM children ≥6 y and \<12 years

Group II: Fosigotifator - Cohort 2Experimental Treatment1 Intervention

Cohort 2: VWM children ≥12 y and \<18 years

Group III: Fosigotifator - Cohort 1bExperimental Treatment1 Intervention

Cohort 1: VWM adults ≥18 years

Group IV: Fosigotifator - Cohort 1Experimental Treatment1 Intervention

Cohort 1: VWM adults ≥18 years

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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

ABBV-CLS-7262 is an investigational drug being studied for its potential to treat Vanishing White Matter Disease (VWMD), a condition characterized by the progressive loss of white matter in the brain. While specific details about ABBV-CLS-7262's mechanism of action are not provided, treatments for VWMD generally aim to stabilize or repair the myelin sheath, reduce inflammation, and protect neural cells from further damage. These mechanisms are crucial for VWMD patients as they help slow disease progression, preserve neurological function, and improve quality of life. By targeting the underlying causes of white matter degeneration, these treatments offer hope for managing a currently incurable and debilitating disease.

Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits.Percutaneous transluminal angioplasty for treatment of chronic cerebrospinal venous insufficiency in people with multiple sclerosis: a summary of a Cochrane systematic review.