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Unknown

Multiple Treatments for ALS

Phase 2 & 3
Recruiting
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
Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
Age 18 years or older
Timeline
Screening 1 weeks
Treatment 18 months
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is for people with ALS who are looking for new treatment options. It is a perpetual trial, which means it is ongoing, and testing multiple products for safety and efficacy.

Who is the study for?
This trial is for adults with ALS, diagnosed as per El Escorial criteria, who can consent and follow study procedures. They must have a vital capacity over 50%, be within 36 months of symptom onset, and able to swallow. Participants on riluzole or edaravone must be on stable doses; those not taking these drugs may join. Exclusions include significant unstable medical conditions, certain lab abnormalities, active cancer (with exceptions), pregnancy/breastfeeding without contraception use, recent investigational drug use for ALS.Check my eligibility
What is being tested?
The HEALEY ALS Platform Trial tests multiple potential treatments for ALS simultaneously: Zilucoplan, Verdiperstat, CNM-Au8, Pridopidine, SLS-005 Trehalose, ABBV-CLS-7262 and DNL343. It's designed to evaluate the safety and effectiveness of these investigational products in slowing down or stopping disease progression.See study design
What are the potential side effects?
Potential side effects are specific to each treatment being tested but generally could include allergic reactions to the compounds used in the medications; gastrointestinal issues like nausea or diarrhea; fatigue; blood-related problems such as anemia or clotting disorders; liver enzyme elevations indicating possible liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ALS.
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I am 18 years old or older.
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My lung function is at least half of what's expected for someone my age, height, and sex.
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I have not taken riluzole, or I have been on a stable dose for at least 30 days.
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I have never taken edaravone or have completed at least one cycle before the screening.

Timeline

Screening ~ 1 weeks
Treatment ~ 18 months
Follow Up ~24 weeks
This trial's timeline: 1 weeks for screening, 18 months 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
Muscle Strength
Respiratory Function
Survival

Side effects data

From 2022 Phase 2 & 3 trial • 163 Patients • NCT04615923
28%
Fall
24%
Muscular weakness
20%
Neuromyopathy
12%
Constipation
12%
Diarrhoea
12%
Nausea
11%
Dysphagia
10%
COVID-19
10%
Fatigue
8%
Dry mouth
8%
Dysarthria
8%
Salivary hypersecretion
7%
Dizziness
7%
Contusion
7%
Oedema peripheral
7%
Arthralgia
7%
Anxiety
7%
Insomnia
7%
Musculoskeletal pain
6%
Complication associated with device
6%
Dyspnoea
5%
Depression
5%
Headache
3%
Muscle contractions involuntary
3%
Gastroesophageal reflux disease
3%
Post lumbar puncture syndrome
2%
Syncope
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pain in extremity
2%
Amyotrophic lateral sclerosis
2%
Cognitive disorder
2%
Skin abrasion
1%
Failure to thrive
1%
Presyncope
1%
Traumatic intracranial haemorrhage
1%
COVID-19 pneumonia
1%
Cerebellar stroke
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Hip fracture
1%
Pneumoperitoneum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pridopidine
Matching Placebo

Trial Design

7Treatment groups
Experimental Treatment
Group I: Regimen G - DNL343Experimental Treatment1 Intervention
Participants are randomized to receive either active DNL343 or matching placebo.
Group II: Regimen F- ABBV-CLS-7262Experimental Treatment1 Intervention
Participants are randomized to receive either active ABBV-CLS-7262 or matching placebo.
Group III: Regimen E - SLS-005 TrehaloseExperimental Treatment1 Intervention
Participants are randomized to receive either active SLS-005 Trehalose or matching placebo.
Group IV: Regimen D - PridopidineExperimental Treatment1 Intervention
Participants are randomized to receive either active Pridopidine or matching placebo.
Group V: Regimen C - CNM-Au8Experimental Treatment1 Intervention
Participants are randomized to receive either active CNM-Au8 or matching placebo.
Group VI: Regimen B - VerdiperstatExperimental Treatment1 Intervention
Participants are randomized to receive either active verdiperstat or matching placebo.
Group VII: Regimen A - ZilucoplanExperimental Treatment1 Intervention
Participants are randomized to receive either active zilucoplan or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilucoplan
2020
Completed Phase 3
~680
Verdiperstat
2019
Completed Phase 3
~610
CNM-Au8
2019
Completed Phase 3
~350
Pridopidine
2020
Completed Phase 3
~580
ABBV-CLS-7262
2023
Completed Phase 1
~30
DNL343
2020
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
1,354 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
1,354 Patients Enrolled for Amyotrophic Lateral Sclerosis
Massachusetts General HospitalOTHER
2,933 Previous Clinical Trials
13,196,995 Total Patients Enrolled
37 Trials studying Amyotrophic Lateral Sclerosis
9,720 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
1,171 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
1,171 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

ABBV-CLS-7262 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04297683 — Phase 2 & 3
Amyotrophic Lateral Sclerosis Research Study Groups: Regimen A - Zilucoplan, Regimen B - Verdiperstat, Regimen C - CNM-Au8, Regimen D - Pridopidine, Regimen E - SLS-005 Trehalose, Regimen F- ABBV-CLS-7262, Regimen G - DNL343
Amyotrophic Lateral Sclerosis Clinical Trial 2023: ABBV-CLS-7262 Highlights & Side Effects. Trial Name: NCT04297683 — Phase 2 & 3
ABBV-CLS-7262 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04297683 — Phase 2 & 3

Frequently Asked Questions

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

Are new volunteers still being accepted for this clinical trial?

"That is correct. The online clinicaltrials.gov registry presently lists this study as recruiting patients. This trial was originally posted on July 14th, 2020 and was last updated October 19th, 2022. The aim is to enroll 800 individuals across 48 sites."

Answered by AI

How many people are being enrolled in this research project?

"In order to accurately test the efficacy of this medication, 800 individuals that fit the given profile must participate in this clinical trial. With study sites in Detroit and San Francisco, there is likely a location convenient for most people that qualify."

Answered by AI

Are there similar drugs to Pridopidine that have undergone clinical testing?

"Pridopidine was first studied in 2019. Out of the 21 clinical trials completed, 6 are still ongoing with many based in San Francisco, California."

Answered by AI

Is this a novel approach to testing?

"There are 6 ongoing trials for Pridopidine in 90 cities and 13 countries. The first trial was sponsored by Ra Pharmaceuticals, Inc. in 2019. That study had 200 participants and completed Phase 3 approval in 2019. 21 other trials have been completed since then."

Answered by AI

In how many different locations is this research project being conducted?

"Currently, there are a total of 48 medical centres operating for this clinical trial. Some notable locations include UCSF in San Francisco, Henry Ford Health System in Detroit, and Saint Alphonsus Regional Medical Center in Boise."

Answered by AI

Who else is applying?

What site did they apply to?
UCSF
Duke University
Wake Forest Health Science
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
HEALEY ALS Platform Trial - Master Protocol
Merit E. Cudkowicz, MD 2020. "HEALEY ALS Platform Trial - Master Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04297683.
All > Lou Gehrigs Disease > Als
~356 spots leftby Jul 2025
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