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NCT03136809
ALS Treatment Extension Study
Phase 1, PHASE2 trial testing Cu(II)ATSM in Amyotrophic Lateral Sclerosis in 28 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Collaborative Medicinal Development Pty Limited |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 18 January 2018 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Cu(II)ATSM — 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
Treatment extension study for ALS/MND patients who participated in phase 1 study CMD-2016-001, completed assessments following six 28-day cycles of treatment, and whom the Investigator considers would benefit from continued CuATSM 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 -
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 -
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 -
Are Astrocytes the Predominant Cell Type for Activation of Nrf2 in Aging and Neurodegeneration?
Liddell JR. · · 2017 · cited 114× · PMID 28820437 · DOI 10.3390/antiox6030065 -
Improving the Delivery of SOD1 Antisense Oligonucleotides to Motor Neurons Using Calcium Phosphate-Lipid Nanoparticles.
Chen L, Watson C, Morsch M, Cole NJ, et al · · 2017 · cited 49× · PMID 28912673 · DOI 10.3389/fnins.2017.00476 -
Cu<sup>II</sup>(atsm) Attenuates Neuroinflammation.
Choo XY, Liddell JR, Huuskonen MT, Grubman A, et al · · 2018 · cited 22× · PMID 30319344 · DOI 10.3389/fnins.2018.00668 -
Astrocytes: Dissecting Their Diverse Roles in Amyotrophic Lateral Sclerosis and Frontotemporal Dementia.
Valori CF, Sulmona C, Brambilla L, Rossi D. · · 2023 · cited 21× · PMID 37296571 · DOI 10.3390/cells12111450 -
CuATSM effectively ameliorates ALS patient astrocyte-mediated motor neuron toxicity in human in vitro models of amyotrophic lateral sclerosis.
Dennys CN, Roussel F, Rodrigo R, Zhang X, et al · · 2023 · cited 15× · PMID 36213964 · DOI 10.1002/glia.24278
Verify or expand the search:
- PubMed search for NCT03136809
- 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
- NCT04082832 — CuATSM Compared With Placebo for Treatment of ALS/MND · Phase 2, PHASE3 · 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
- NCT04082832 — CuATSM Compared With Placebo for Treatment of ALS/MND · Phase 2, PHASE3 · 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 NCT03136809 (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: 17 February 2022
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/NCT03136809.
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