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Nanoparticle

CNM-Au8 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 24 weeks

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug for ALS called CNM-Au8.

Eligible Conditions

ALS (Amyotrophic Lateral Sclerosis)

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 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 2023 Phase 2 & 3 trial • 161 Patients • NCT04414345

22%

Fall

20%

Muscular weakness

19%

Diarrhoea

14%

Nausea

14%

Constipation

14%

Headache

13%

Dysarthria

12%

Neuromyopathy

11%

Fatigue

11%

Dyspnoea

Urinary tract infection

Dysphagia

Cough

Tension headache

Oedema peripheral

Sinusitis

Amyotrophic lateral sclerosis

Arthralgia

Pruritus

Vomiting

Skin laceration

Pulmonary embolism

Decreased Appetite

Depression

Respiratory failure

Post-traumatic pain

COVID-19

Weight Decreased

Malnutrition

Sepsis

Syncope

Complication associated with device

Failure to thrive

Foot fracture

Chest pain

Rib fracture

100%

80%

60%

40%

20%

Study treatment Arm

CNM-Au8

Matching Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CNM-Au8Experimental Treatment1 Intervention

Drug: CNM-Au8 Administration: Oral Dosage: 30 mg or 60 mg daily

Group II: Matching PlaceboPlacebo Group1 Intervention

Administration: Oral Dosage: 2 bottles daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CNM-Au8

2019

Completed Phase 3

~350

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

2,693 Total Patients Enrolled

7 Trials studying Amyotrophic Lateral Sclerosis

2,693 Patients Enrolled for Amyotrophic Lateral Sclerosis

Clene NanomedicineIndustry Sponsor

11 Previous Clinical Trials

638 Total Patients Enrolled

5 Trials studying Amyotrophic Lateral Sclerosis

85 Patients Enrolled for Amyotrophic Lateral Sclerosis

Merit CudkowiczPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

162 Total Patients Enrolled

1 Trials studying Amyotrophic Lateral Sclerosis

162 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.

Is this study still looking for volunteers?

"At present, this clinical trial is not looking for any new patients. The most recent update on the website was from June 25th, 2022 and it was originally posted on July 30th, 2020. Although this study isn't searching for subjects right now, there are plenty of other medical trials that are."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HEALEY ALS Platform Trial - Regimen C CNM-Au8

Merit E. Cudkowicz, MD 2020. "HEALEY ALS Platform Trial - Regimen C CNM-Au8". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04414345.