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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

Awards & highlights

Study Summary

This trial evaluates safety & effectiveness of a potential treatment for ALS. It tests a single study drug to see if it can help people with 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Disease Progression

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merit E. Cudkowicz, MDLead Sponsor

7 Previous Clinical Trials

2,554 Total Patients Enrolled

7 Trials studying Amyotrophic Lateral Sclerosis

2,554 Patients Enrolled for Amyotrophic Lateral Sclerosis

Calico Life Sciences LLCIndustry Sponsor

8 Previous Clinical Trials

658 Total Patients Enrolled

1 Trials studying Amyotrophic Lateral Sclerosis

31 Patients Enrolled for Amyotrophic Lateral Sclerosis

Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

2,371 Total Patients Enrolled

8 Trials studying Amyotrophic Lateral Sclerosis

2,371 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

ABBV-CLS-7262 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05740813 — Phase 2 & 3

Amyotrophic Lateral Sclerosis Research Study Groups: Matching Placebo, ABBV-CLS-7262 Dose 1, ABBV-CLS-7262 Dose 2

Amyotrophic Lateral Sclerosis Clinical Trial 2023: ABBV-CLS-7262 Highlights & Side Effects. Trial Name: NCT05740813 — Phase 2 & 3

ABBV-CLS-7262 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05740813 — Phase 2 & 3

Frequently Asked Questions

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

Is this research endeavor currently accepting participants?

"According to the clinicaltrials.gov, this medical study is not presently recruiting participants. The trial was initially posted on March 23rd 2023 and its latest update happened April 24th 2023. Nevertheless, there are currently 124 other trials actively searching for patients."

Answered by AI

Do I fulfill the prerequisites to participate in this scientific investigation?

"This investigation is actively attempting to enroll 240 individuals suffering from amyotrophic lateral sclerosis. The age range for the trial starts at 18, extending up to 100 years old. Moreover, participants must meet all other criteria specified in the Master Protocol (NCT NCT04297683)."

Answered by AI

Does this experiment demand participants of a certain age or older?

"This particular study requires applicants to be aged between 18 and 100 years. There are 7 separate medical trials for minors, while seniors can take part in 123 different clinical studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262

Merit E. Cudkowicz, MD 2023. "HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05740813.

All > Lou Gehrigs Disease > Als