What side effects are associated with this type of intervention?

Common treatments for ALS, such as riluzole, edaravone, and sodium phenylbutyrate-taurursodiol, have known side effects. Riluzole can cause nausea, weakness, decreased lung function, and liver enzyme abnormalities. Edaravone may lead to bruising, gait disturbances, headaches, and allergic reactions. Sodium phenylbutyrate-taurursodiol is associated with gastrointestinal issues like diarrhea, abdominal pain, and nausea. Investigational drugs targeting ALS pathways may also have side effects such as vomiting, decreased appetite, weight loss, and hypertension. Patients should discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Amyotrophic Lateral Sclerosis (ALS). Riluzole, approved in 1995, works by reducing glutamate-induced excitotoxicity. Edaravone, approved in 2017, is thought to act as a free radical scavenger, reducing oxidative stress. These drugs aim to slow disease progression and improve quality of life. The investigational drug ABBV-CLS-7262, currently being studied in the HEALEY ALS Platform Trial, likely targets similar pathways implicated in ALS pathology, although its specific mechanism of action has not been detailed.

What other types of research exist?

Promising novel alternatives to ABBV-CLS-7262 for ALS patients in 2024 include: 1) Tofersen, an antisense oligonucleotide targeting SOD1 mutations, 2) AMX0035, a combination of sodium phenylbutyrate and taurursodiol aimed at reducing neuronal death, and 3) Reldesemtiv, a fast skeletal muscle troponin activator designed to improve muscle function. These treatments are in advanced stages of clinical trials and show potential in addressing different aspects of ALS pathology.

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Unknown

ABBV-CLS-7262 for ALS

Phase 2 & 3

Waitlist Available

Led By Merit Cudkowicz, MD

Research Sponsored by Merit E. Cudkowicz, MD

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 24 weeks

Summary

This trial is testing a new drug called ABBV-CLS-7262 to see if it can help people with ALS. ALS is a serious disease with few treatments, so new options are needed. The drug aims to improve symptoms or slow down the disease.

Who is the study for?

This trial is for people with ALS, also known as Lou Gehrig's disease. Participants must meet the general criteria set by the master protocol (NCT04297683). They can't join if they have significant heart rhythm problems, abnormal lab test results, or are taking certain drugs that affect enzyme activity in the body.

What is being tested?

The HEALEY ALS Platform Trial is testing ABBV-CLS-7262 at two different doses to see if it's safe and effective for treating ALS. Some participants will receive a placebo instead to compare outcomes.

What are the potential side effects?

Specific side effects of ABBV-CLS-7262 aren't listed here, but typically trials look out for any new symptoms like headaches, nausea, fatigue or reactions at the injection site which could be related to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

Disease Progression

Secondary study objectives

Disease Progression Biomarker

Muscle Strength

Respiratory Function

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ABBV-CLS-7262 Dose 2Experimental Treatment1 Intervention

Group II: ABBV-CLS-7262 Dose 1Experimental Treatment1 Intervention

Group III: Matching PlaceboPlacebo Group1 Intervention

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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

The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol. Riluzole works by inhibiting glutamate release, which helps reduce excitotoxicity—a key factor in motor neuron death in ALS. Edaravone acts as an antioxidant, reducing oxidative stress and slowing functional decline. Sodium phenylbutyrate-taurursodiol combines two drugs that reduce neuronal cell death by targeting mitochondrial and endoplasmic reticulum stress. These treatments are crucial for ALS patients as they aim to slow disease progression and improve quality of life. The trial drug ABBV-CLS-7262 likely targets similar pathological pathways, emphasizing the importance of understanding and intervening in the underlying mechanisms of ALS.

Translating biological findings into new treatment strategies for amyotrophic lateral sclerosis (ALS).