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CNM-Au8

DRUG9 trials

Sponsors

Clene Nanomedicine, Merit E. Cudkowicz, MD

Conditions

ALSAmyotrophic Lateral SclerosisHealthy Volunteers - Male and FemaleMultiple SclerosisOptic NeuropathyOptic; Neuritis, With DemyelinationPALSRelapsing Multiple Sclerosis

Phase 1

A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers
CompletedNCT02755870
Clene NanomedicineHealthy Volunteers - Male and Female
Start: 2015-04-30End: 2016-10-31Updated: 2019-06-03

Phase 2

Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
TerminatedNCT03536559
Clene NanomedicineOptic; Neuritis, With Demyelination, Optic Neuropathy, Relapsing Remitting Multiple Sclerosis
Start: 2018-11-23End: 2022-07-12Updated: 2023-04-03
Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)
CompletedNCT04098406
Clene NanomedicineAmyotrophic Lateral Sclerosis
Start: 2019-12-19End: 2021-07-13Updated: 2024-07-03
HEALEY ALS Platform Trial - Master Protocol
RecruitingNCT04297683
Merit E. Cudkowicz, MDAmyotrophic Lateral Sclerosis
Start: 2020-06-14End: 2028-08-01Target: 1500Updated: 2026-03-27
HEALEY ALS Platform Trial - Regimen C CNM-Au8
CompletedNCT04414345
Merit E. Cudkowicz, MDAmyotrophic Lateral Sclerosis
Start: 2020-07-30End: 2023-03-07Updated: 2023-07-25
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
CompletedNCT04626921
Clene NanomedicineRelapsing Multiple Sclerosis
Start: 2020-10-22End: 2023-09-06Updated: 2023-12-08

Unknown Phase

Intermediate Expanded Access Protocol CNMAu8.EAP03
NCT04081714
Clene NanomedicineMultiple Sclerosis
Updated: 2025-12-24
Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS
NCT05281484
Clene NanomedicineAmyotrophic Lateral Sclerosis
Updated: 2026-03-27
Intermediate Expanded Access Protocol CNMAu8.EAP04
NCT06408727
Clene NanomedicineALS, Amyotrophic Lateral Sclerosis, PALS
Updated: 2025-01-28

Related Papers

Efficacy and Safety of Zilucoplan in Amyotrophic Lateral Sclerosis
JAMA Network Open2025-02-1711 citations
Pridopidine in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
2025-02-178 citations
CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
2025-02-176 citations
Verdiperstat in Amyotrophic Lateral Sclerosis: Results From the Randomized HEALEY ALS Platform Trial.
2025-02-176 citations
Efficacy and safety of CNM-Au8 in amyotrophic lateral sclerosis (RESCUE-ALS study): a phase 2, randomised, double-blind, placebo-controlled trial and open label extension.
2023-06-0834 citations
Results from the first four regimens of the HEALEY ALS Platform Trial (PL5.004)
Neurology2023-04-254 citations
Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease
BMJ Open2022-07-0134 citations
Study protocol of RESCUE-ALS: A Phase 2, randomised, double-blind, placebo-controlled study in early symptomatic amyotrophic lateral sclerosis patients to assess bioenergetic catalysis with CNM-Au8 as a mechanism to slow disease progression
BMJ Open2021-01-0149 citations