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Monoclonal Antibodies

Zilucoplan for Amyotrophic Lateral Sclerosis

Phase 2 & 3

Waitlist Available

Led By Merit Cudkowicz

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 baseline and 24 weeks

Awards & highlights

Study Summary

This trial will help researchers learn more about how zilucoplan works in people with ALS, what the side effects are, and how well it works.

Eligible Conditions

ALS (Amyotrophic Lateral Sclerosis)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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 as Assessed by the ALSFRS-R Total Score

Mortality Event Rate

Secondary outcome measures

Muscle Strength

Number of Participants That Experienced Death or Death Equivalent

Respiratory Function

Side effects data

From 2022 Phase 2 & 3 trial • 162 Patients • NCT04436497

32%

Fall

24%

Muscular weakness

18%

Neuromyopathy

18%

Injection site bruising

15%

Injection site pain

14%

Fatigue

11%

Constipation

11%

Headache

10%

Dizziness

10%

Dysphagia

Nausea

Diarrhoea

Cough

Dysarthria

Oedema peripheral

Rash

Contusion

Anxiety

Dyspnoea

Pruritus

Respiratory Failure

Tension headache

Urinary tract infection

Decreased appetite

Arthralgia

Hypertension

Pain in extremity

Injection site reaction

Salivary hypersecretion

Pneumonia aspiration

Pulmonary embolism

COVID-19

Post-traumatic pain

Generalised oedema

Vomiting

Faecaloma

COVID-19 pneumonia

Pneumonia

Oesophageal carcinoma

Device malfunction

Hepatic enzyme increased

Cardiac arrest

Cardiac failure congestive

Supraventricular tachycardia

Deep vein thrombosis

Traumatic haematoma

Tinnitus

Increased upper airway secretion

Pancreatitis

Pneumoperitoneum

Chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Zilucoplan

Matching Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZilucoplanExperimental Treatment1 Intervention

Drug: Zilucoplan Administration: Subcutaneous injection Dosage: 0.3mg/kg administered daily

Group II: Matching PlaceboPlacebo Group1 Intervention

Administration: Subcutaneous injection Dosage: Daily subcutaneous injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zilucoplan

2020

Completed Phase 3

~680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ra PharmaceuticalsIndustry Sponsor

7 Previous Clinical Trials

494 Total Patients Enrolled

Merit E. Cudkowicz, MDLead Sponsor

7 Previous Clinical Trials

2,692 Total Patients Enrolled

7 Trials studying Amyotrophic Lateral Sclerosis

2,692 Patients Enrolled for Amyotrophic Lateral Sclerosis

Merit CudkowiczPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

161 Total Patients Enrolled

1 Trials studying Amyotrophic Lateral Sclerosis

161 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

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

How many test subjects are being recruited for this experiment?

"At the moment, this study is not looking for new participants. According to the date stamps on clinicaltrials.gov, this trial was first posted on July 29th 2020 and last edited June 25th 2022. There are numerous other trials with similar eligibility criteria that are currently looking for patients; For example, there are 136 studies involving amyotrophic lateral sclerosis and 3 Zilucoplan trials actively admitting candidates right now."

Answered by AI

Are patients still being sought for participation in this clinical trial?

"This clinical trial is no longer recruiting participants. The study was posted on 7/29/2020 and edited on 6/25/2022. There are currently 136 other studies related to amyotrophic lateral sclerosis that are actively recruiting patients as well as 3 Zilucoplan trials."

Answered by AI

Is this a groundbreaking clinical trial?

"Zilucoplan was first trialled in 2019 by Ra Pharmaceuticals, Inc. and has been the subject of 3 clinical studies since then. The most recent trials were completed in 81 different cities across 10 nations and approved Zilucoplan for Phase 3 drugs."

Answered by AI

What other scientific investigations have included Zilucoplan?

"There are a total of 3 clinical trials underway for Zilucoplan, with the majority of these being in Phase 3. The medication's tests are mostly based out of Columbus, Ohio, but there are 212 different locations running studies on it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEALEY ALS Platform Trial - Regimen A Zilucoplan

Merit E. Cudkowicz, MD 2020. "HEALEY ALS Platform Trial - Regimen A Zilucoplan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436497.