What side effects are associated with this type of intervention?

Common treatments for ALS, such as dexpramipexole and ozanezumab, have shown varying side effects. Dexpramipexole was generally well tolerated but did not show significant efficacy, with some participants developing neutropenia. Ozanezumab, another investigational drug, did not demonstrate efficacy and was associated with a higher number of deaths due to respiratory failure compared to placebo. These treatments highlight the challenges in managing ALS, with side effects including neutropenia and increased mortality risk due to respiratory complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Amyotrophic Lateral Sclerosis (ALS) that target neuroprotection, inflammation, or cellular stress responses. Riluzole, approved in 1995, is believed to reduce damage to motor neurons by decreasing the release of glutamate. Edaravone, approved in 2017, is thought to act as a free radical scavenger, reducing oxidative stress in neurons. More recently, in 2022, the combination of sodium phenylbutyrate and taurursodiol (AMX0035) was approved, which aims to protect neurons by reducing endoplasmic reticulum stress and mitochondrial dysfunction. These treatments share a focus on mitigating cellular stress and protecting neuronal health, similar to the investigational drug ABBV-CLS-7262.

What other types of research exist?

Promising alternatives to ABBV-CLS-7262 for ALS patients 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 that improves muscle function. These treatments are in advanced stages of clinical trials and show potential in addressing neuroprotection and cellular stress responses.

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ABBV-CLS-7262 for ALS

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Able to swallow solids

No known active COVID-19 infection at screening

Must not have

If male, plans to donate sperm or father a child during the study or within 30 days after the last dose of study drug

History of ABBV-CLS-7262 use prior to participation in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately week 156

Summary

This trial is testing a new drug called ABBV-CLS-7262 to see if it can help people with Amyotrophic Lateral Sclerosis (ALS). The study will have two parts: an initial short phase where some people get the drug, followed by a longer phase where everyone gets the drug. The goal is to see if the drug can protect nerve cells and slow down the disease.

Who is the study for?

This trial is for people with ALS who've had symptoms start within the last 3 years and can swallow solids. They need a reliable caregiver, no recent drug abuse, or severe cognitive issues. Participants should not be using certain ALS treatments like diaphragmatic pacing or have been in stem cell studies for ALS.

What is being tested?

ABBV-CLS-7262, a new potential treatment for ALS, is being tested against a placebo over up to 156 weeks. Initially, there's a 4-week double-blind phase where participants won't know if they're getting the real drug or placebo, followed by an active treatment extension where all get ABBV-CLS-7262.

What are the potential side effects?

Since ABBV-CLS-7262 is investigational, specific side effects are unknown but may include typical drug reactions such as nausea, headaches, allergic responses or other unforeseen issues that will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow solid foods.

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I do not have an active COVID-19 infection.

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I have been diagnosed with ALS, either familial or sporadic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a male and do not plan to father a child during or within 30 days after the study.

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I have never used ABBV-CLS-7262 before this study.

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I use a tracheostomy or a breathing support machine for most of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately week 156 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pharmacokinetics

Secondary study objectives

CSF Pharmacokinetics

Safety and Tolerability

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Fosigotifator Low DoseActive Control1 Intervention

Group II: Fosigotifator High DoseActive Control1 Intervention

Group III: Fosigotifator Medium DoseActive Control1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

0 / 6Eligibility criteria met

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

Common treatments for Lou Gehrig's Disease (ALS) often target neuroprotection, inflammation, and cellular stress responses. Neuroprotective agents, such as riluzole and edaravone, work by reducing excitotoxicity and oxidative stress, which can slow the progression of neuronal damage. Anti-inflammatory treatments aim to reduce the chronic inflammation that contributes to motor neuron degeneration. Cellular stress response modulators, like the investigational drug ABBV-CLS-7262, may help by enhancing the cells' ability to manage stress and prevent apoptosis. These mechanisms are crucial for ALS patients as they can potentially slow disease progression, improve quality of life, and extend survival.

Protective Effects of Leukadherin1 in a Rat Model of Targeted Experimental Autoimmune Encephalomyelitis (EAE): Possible Role of P47phox and MDA Downregulation.Long-term interleukin-33 treatment delays disease onset and alleviates astrocytic activation in a transgenic mouse model of amyotrophic lateral sclerosis.The Antioxidant Effects of Thymoquinone in Activated BV-2 Murine Microglial Cells.