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NCT04082832

CuATSM Compared With Placebo for Treatment of ALS/MND

Status unknown Phase 2, PHASE3 Last updated 6 November 2019
What this trial tests

Phase 2, PHASE3 trial testing Cu(II)ATSM in Amyotrophic Lateral Sclerosis in 80 participants. Status unknown.

Timeline
30 September 2019
Primary endpoint
30 December 2020
30 December 2020

Quick facts

Lead sponsorCollaborative Medicinal Development Pty Limited
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment80
Start date30 September 2019
Primary completion30 December 2020
Estimated completion30 December 2020
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Collaborative Medicinal Development Pty Limited — full company profile →

Who can join

Adults 18 to 75, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multicenter, randomized, double-blind, placebo controlled study to assess the tolerabilty and efficacy of CuATSM in patients with ALS/MND. Patients will be randomized 1:1 to CuATSM or placebo for 6 x 28-day cycles (24 weeks) of treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Molecular mechanisms of cell death in neurological diseases.
    Moujalled D, Strasser A, Liddell JR. · · 2021 · cited 513× · PMID 34099897 · DOI 10.1038/s41418-021-00814-y
  2. Copper Dyshomeostasis in Neurodegenerative Diseases-Therapeutic Implications.
    Gromadzka G, Tarnacka B, Flaga A, Adamczyk A. · · 2020 · cited 226× · PMID 33291628 · DOI 10.3390/ijms21239259
  3. Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
    Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
  4. Getting out what you put in: Copper in mitochondria and its impacts on human disease.
    Cobine PA, Moore SA, Leary SC. · · 2021 · cited 197× · PMID 32979421 · DOI 10.1016/j.bbamcr.2020.118867
  5. Superoxide Dismutase 1 in Health and Disease: How a Frontline Antioxidant Becomes Neurotoxic.
    Trist BG, Hilton JB, Hare DJ, Crouch PJ, et al · · 2021 · cited 148× · PMID 32144830 · DOI 10.1002/anie.202000451
  6. Copper Ions and Parkinson's Disease: Why Is Homeostasis So Relevant?
    Bisaglia M, Bubacco L. · · 2020 · cited 147× · PMID 32013126 · DOI 10.3390/biom10020195
  7. Regional brain iron associated with deterioration in Alzheimer's disease: A large cohort study and theoretical significance.
    Ayton S, Portbury S, Kalinowski P, Agarwal P, et al · · 2021 · cited 145× · PMID 33491917 · DOI 10.1002/alz.12282
  8. Homeostasis and metabolism of iron and other metal ions in neurodegenerative diseases.
    Chen L, Shen Q, Liu Y, Zhang Y, et al · · 2025 · cited 119× · PMID 39894843 · DOI 10.1038/s41392-024-02071-0

Verify or expand the search:

Other trials of Cu(II)ATSM

Trials testing the same drug.

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

Other Collaborative Medicinal Development Pty Limited trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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