Adults 30 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Electromyography Measures of Disease Progression.Primary· 36 weeks
The Motor Unit Number Index (MUNIX) is a quantitative neurophysiological measure that provides an index of the number of lower motor neurons supplying a muscle. It reflects the loss of motor neurons in patients with ALS. Mean change in the average difference between active treatment and placebo from Baseline through Week 36 for the MUNIXscore(4), which is the sum of the respective MUNIX values for the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), and Tibialis Anterior (TA). The average baseline summed values will be indexed to 100%. Changes will be calculat
Group
Value
95% CI
Placebo
-39.6
± 7.1
30 mg CNM-Au8
-31.8
± 6.6
Percentage Mean Change in the Average Difference Between Active Treatment and Placebo From Baseline for Respiratory Function as Measured by Forced Vital Capacity (FVC).Secondary· 36 weeks
Mean change in FVC - Forced Vital Capacity.
Group
Value
95% CI
Placebo
-20.3
± 5.8
30 mg CNM-Au8
-16.7
± 5.4
Mean Absolute Change of the Average Difference Between Active Treatment and Placebo From Baseline Through Week 36 for the MUNIXscore(4).Secondary· 36 weeks
The Motor Unit Number Index (MUNIX) is a quantitative neurophysiological measure that provides an index of the number of lower motor neurons supplying a muscle. It reflects the loss of motor neurons in patients with ALS. MUNIX will be reviewed via electromyography for the Abductor Pollicus Brevis (APB), Abductor Digiti Minimi (ADM), Biceps Brachii (BB), and Tibialis Anterior (TA). MUNIXscore(4) is the sum of the respective MUNIX values for the above mentioned muscle groups. A higher MUNIX value signifies greater muscle function. A greater decrease in the Mean absolute change signifies worsenin
Group
Value
95% CI
Placebo
-141.3
± 27
30 mg CNM-Au8
-123.6
± 25
Mean Change in Average ALSFRS-R ScoreSecondary· 36 weeks
The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated rating instrument for monitoring the progression of disability in patients with ALS. Maximum score is 40, minimum is 0. A higher score signifies greater function.
Group
Value
95% CI
Placebo
-5.8
± 0.9
30 mg CNM-Au8
-4.8
± 0.8
Mean Change Between Active Treatment and Placebo in the Proportion of Patients Experiencing a > 6-point Decline in the ALSFRS-R Between Active Treatment and Placebo.Secondary· 36 weeks
Mean Change Between Active Treatment and Placebo for the Combined Assessment of Function and Survival (CAFS), a Joint-rank Analysis of Function (ALSFRS-R) and Overall SurvivalSecondary· 36 weeks
the Combined Assessment of Function and Survival (CAFS). CAFS ranks patients' clinical outcomes based on survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Each patient's outcome is compared to every other patient's outcome, assigned a score, and the summed scores are ranked. The mean rank score for each treatment group can then be calculated. A higher mean CAFS score indicates a better group outcome. There is no maximum or minimum due to ranking.
Group
Value
95% CI
Placebo
-4.6
± 5.2
30 mg CNM-Au8
4.4
± 5.1
Time to ALS Clinical WorseningSecondary· 36 weeks
ALS Clinical Worsening is defined as the occurrence of death, tracheostomy, use of non-invasive ventilatory respiratory support, insertion of a gastrostomy tube, or a 6-point drop in the ALSFRS-R score. This outcome measures the number of participants that experienced ALS clinical worsening event within the 36 week time frame.
Group
Value
95% CI
Placebo
13
30 mg CNM-Au8
5
Mean Change in Average Difference Between Active Treatment and Placebo for the ALSSQOL-Short Form Questionnaire (ALSSQOL-SF)Secondary· 36 weeks
ALS Specific Quality of Life - Short Form (ALSSQOL-SF) Questionnaire will be completed at multiple times during the trial and the scores will be averaged. Maximum score is 10, minimum score is 0. A higher score signifies a higher quality of life.
Group
Value
95% CI
Placebo
-1.2
± 0.3
30 mg CNM-Au8
-0.3
± 0.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the time of the signing of the Informed Consent to 28 days after the last day of study drug administration, up to 46 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this trial was to assess the efficacy, safety, and PK/PD effects of CNM-Au8 as a disease-modifying agent for the treatment of ALS by utilizing electrophysiological measures to detect preservation of motor neuron function. The primary endpoint was the mean change in the average difference between active treatment and placebo from Baseline through Week 36 evaluated by electromyography.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04626921 — A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
· Phase 2, PHASE3
· completed
NCT04414345 — HEALEY ALS Platform Trial - Regimen C CNM-Au8
· Phase 2, PHASE3
· completed
NCT03536559 — Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
· Phase 2
· terminated
NCT05281484 — Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS
· no longer available
NCT06408727 — Intermediate Expanded Access Protocol CNMAu8.EAP04
· temporarily not available
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Other Clene Nanomedicine trials
Trials by the same sponsor.
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NCT04626921 — A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
· Phase 2, PHASE3
· completed
NCT03815916 — 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
· Phase 2
· completed
NCT03993171 — 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.
· Phase 2
· completed
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· Phase 2
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clene Nanomedicine
Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04098406.