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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

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 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 Total Score
Mortality Event Rate
Secondary study objectives
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
8%
Dysphagia
8%
Urinary tract infection
6%
Tension headache
6%
Cough
6%
Oedema peripheral
5%
Arthralgia
5%
Amyotrophic lateral sclerosis
5%
Vomiting
5%
Skin laceration
5%
Sinusitis
5%
Pruritus
4%
Pulmonary embolism
4%
Decreased Appetite
3%
Respiratory failure
3%
Post-traumatic pain
3%
Depression
2%
Weight Decreased
2%
COVID-19
1%
Sepsis
1%
Syncope
1%
Foot fracture
1%
Chest pain
1%
Failure to thrive
1%
Complication associated with device
1%
Malnutrition
1%
Rib fracture
100%
80%
60%
40%
20%
0%
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

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
12 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
~31 spots leftby Oct 2025
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