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ABBV-CLS-7262 for ALS

Phase 1

Waitlist Available

Research Sponsored by Calico Life Sciences LLC

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately week 156

Awards & highlights

Study Summary

This trial is testing a new ALS drug. It is 48 weeks long, has 2 parts, and involves regular check-ups and assessments.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetics

Secondary outcome measures

CSF Pharmacokinetics

Safety and Tolerability

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: ABBV-CLS-7262 HIGH DOSEActive Control1 Intervention

Group II: ABBV-CLS-7262 MEDIUM DOSEActive Control1 Intervention

Group III: ABBV-CLS-7262 LOW DOSEActive Control1 Intervention

Group IV: PLACEBOPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Calico Life Sciences LLCLead Sponsor

8 Previous Clinical Trials

927 Total Patients Enrolled

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,074 Total Patients Enrolled

Media Library

ABBV-CLS-7262 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04948645 — Phase 1

Lou Gehrig's Disease Research Study Groups: ABBV-CLS-7262 HIGH DOSE, PLACEBO, ABBV-CLS-7262 MEDIUM DOSE, ABBV-CLS-7262 LOW DOSE

Lou Gehrig's Disease Clinical Trial 2023: ABBV-CLS-7262 Highlights & Side Effects. Trial Name: NCT04948645 — Phase 1

ABBV-CLS-7262 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948645 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility I could be enrolled in this experiment?

"This research is hoping to recruit 30 people with amyotrophic lateral sclerosis, ranging in age from 18-80. They must also possess the following characteristics: an identified caregiver, confirmed ALS diagnosis, initial symptoms within 36 months of screening, able to swallow solids, no active COVID infection at screening timepoint; vital capacity greater than 50% predicted value for sex/age/ethnicity/height; naivety or cessation of edaravone (Radicava) treatment and same regarding riluzole (Rilutek)."

Answered by AI

What is the current participation number for this trial?

"This clinical trial necessitates 30 qualified patients for participation. Montreal Neurological Institute and Hospital in Montreal, Quebec as well as UC Irvine Health ALS and Neuromuscular Center in Rochester Minnesota are two of the multiple locations where individuals can take part."

Answered by AI

What sort of risks have been established with ABBV-CLS-7262 HIGH DOSE?

"As ABBV-CLS-7262 HIGH DOSE is a Phase 1 trial, there is scant evidence of the drug's efficacy and safety. Thus, Power rated this medication on its scale from 1 to 3 as one point."

Answered by AI

How many medical centers are hosting this research initiative?

"Numerous medical facilities are partaking in the trial, including Montreal Neurological Institute and Hospital, UC Irvine Health ALS and Neuromuscular Center, Mayo Clinic of Fredericton, alongside 11 other locations."

Answered by AI

Is this research program actively seeking elderly participants?

"Participants of this research must have an age between 18 and 80 years. Of the 446 trials conducted, 44 are for minors while 402 cater to seniors over 65."

Answered by AI

Is this research scenario currently seeking participants?

"Indeed, the data found on clinicaltrials.gov demonstrates that this medical trial is actively recruiting participants. This research was first announced on September 22nd 2021 and had a most recent edit to it on June 16th 2022. There are 14 sites from which 30 people must be recruited for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis

2021. "A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948645.

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