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HEALEY ALS Platform Trial - Regimen B Verdiperstat

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

Summary

This trial is testing Verdiperstat, a drug that might help people with ALS. It aims to see if Verdiperstat can safely and effectively treat ALS symptoms. Participants with ALS will receive Verdiperstat.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)
  • Amyotrophic Lateral Sclerosis

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Progression as Assessed by the ALSFRS-R-Slope
Mortality Even Rate
Secondary study objectives
Muscle Strength
Number of Participants That Experienced Death or Death Equivalent
Respiratory Function

Side effects data

From 2022 Phase 2 & 3 trial • 167 Patients • NCT04436510
28%
Nausea
21%
Headache
20%
Insomnia
19%
Fall
19%
Constipation
17%
Muscular weakness
16%
Fatigue
13%
Neuromyopathy
10%
Tension headache
10%
Dizziness
10%
Decreased appetite
10%
Dysphagia
9%
Blood thyroid stimulating hormone increased
8%
Dyspnoea
8%
Diarrhoea
8%
Urinary tract infection
8%
Salivary hypersecretion
7%
Anxiety
6%
Urine odour abnormal
6%
Cough
6%
Back pain
6%
Arthralgia
6%
Oedema peripheral
3%
Pain in extremity
3%
Dysarthria
2%
Pulmonary embolism
2%
Respiratory failure
2%
Amyotrophic lateral sclerosis
2%
Febrile neutropenia
1%
Bacteraemia
1%
Abdominal pain
1%
Cerebral infarction
1%
Deep vein thrombosis
1%
B-cell lymphoma
1%
Acute respiratory failure
1%
COVID-19
1%
COVID-19 pneumonia
1%
Dehydration
1%
Sudden death
1%
Aphasia
1%
Bacterial sepsis
1%
Failure to thrive
1%
Hip fracture
1%
Ileus
1%
Hepatic enzyme abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Verdiperstat
Matching Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VerdiperstatExperimental Treatment1 Intervention
Verdiperstat is administered twice daily p.o. for 24 weeks.
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo is administered twice daily p.o. for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verdiperstat
2019
Completed Phase 3
~610

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Industry Sponsor
48 Previous Clinical Trials
37,434 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
22 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
2,687 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
2,687 Patients Enrolled for Amyotrophic Lateral Sclerosis
Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
2,504 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,504 Patients Enrolled for Amyotrophic Lateral Sclerosis
~31 spots leftby Dec 2025
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