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NCT04082832
CuATSM Compared With Placebo for Treatment of ALS/MND
Phase 2, PHASE3 trial testing Cu(II)ATSM in Amyotrophic Lateral Sclerosis in 80 participants. Status unknown.
30 December 2020
Quick facts
| Lead sponsor | Collaborative Medicinal Development Pty Limited |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 30 September 2019 |
| Primary completion | 30 December 2020 |
| Estimated completion | 30 December 2020 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Cu(II)ATSM — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
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):
-
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 -
Copper Dyshomeostasis in Neurodegenerative Diseases-Therapeutic Implications.
Gromadzka G, Tarnacka B, Flaga A, Adamczyk A. · · 2020 · cited 226× · PMID 33291628 · DOI 10.3390/ijms21239259 -
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 -
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 -
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 -
Copper Ions and Parkinson's Disease: Why Is Homeostasis So Relevant?
Bisaglia M, Bubacco L. · · 2020 · cited 147× · PMID 32013126 · DOI 10.3390/biom10020195 -
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 -
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:
- PubMed search for NCT04082832
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cu(II)ATSM
Trials testing the same drug.
- NCT04313166 — Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001 · Phase 2 · completed
- NCT03136809 — ALS Treatment Extension Study · Phase 1, PHASE2 · unknown
- NCT03204929 — Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease · Phase 1 · completed
- NCT02870634 — Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND · Phase 1 · completed
Other recruiting trials for Amyotrophic Lateral Sclerosis
Currently open trials in the same condition.
- NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
- NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
- NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
- NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
- NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting
Other Collaborative Medicinal Development Pty Limited trials
Trials by the same sponsor.
- NCT04313166 — Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001 · Phase 2 · completed
- NCT03136809 — ALS Treatment Extension Study · Phase 1, PHASE2 · unknown
- NCT03204929 — Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease · Phase 1 · completed
- NCT02870634 — Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND · Phase 1 · completed
- NCT02688101 — Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04082832 (US National Library of Medicine, public domain)
- 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 Collaborative Medicinal Development Pty Limited
- Last refreshed: 6 November 2019
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/NCT04082832.
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