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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 week
Treatment 18 months
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 week
Treatment ~ 18 months
Follow Up ~24 weeks
This trial's timeline: 1 week for screening, 18 months 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
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%
Diarrhoea
12%
Constipation
12%
Nausea
11%
Dysphagia
10%
Fatigue
10%
COVID-19
8%
Dysarthria
8%
Salivary hypersecretion
8%
Dry mouth
7%
Contusion
7%
Dizziness
7%
Oedema peripheral
7%
Arthralgia
7%
Musculoskeletal pain
7%
Insomnia
7%
Anxiety
6%
Complication associated with device
6%
Dyspnoea
5%
Headache
5%
Depression
3%
Post lumbar puncture syndrome
3%
Muscle contractions involuntary
3%
Gastroesophageal reflux disease
2%
Amyotrophic lateral sclerosis
2%
Syncope
2%
Cognitive disorder
2%
Respiratory failure
2%
Atrial fibrillation
2%
Skin abrasion
2%
Pain in extremity
1%
COVID-19 pneumonia
1%
Cerebellar stroke
1%
Presyncope
1%
Hip fracture
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Pneumoperitoneum
1%
Failure to thrive
1%
Traumatic intracranial haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pridopidine
Matching Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Pridopidine
2020
Completed Phase 3
~580
ABBV-CLS-7262
2023
Completed Phase 1
~110
DNL343
2020
Completed Phase 1
~160
CNM-Au8
2019
Completed Phase 3
~350
Zilucoplan
2020
Completed Phase 3
~680
Verdiperstat
2019
Completed Phase 3
~610

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
3,015 Previous Clinical Trials
13,307,860 Total Patients Enrolled
38 Trials studying Amyotrophic Lateral Sclerosis
12,360 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
~178 spots leftby Jul 2025
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