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Clinical Trial Summary

Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study


Clinical Trial Description

Multicenter, open-label, phase 1 study of Cu(II)ATSM administered orally to patients wit amyotrophic lateral sclerosis/motor neuron disease. The study will be conducted in three phases. In the first two phases, dose cohorts of six patients each will participate in a single dose pharmacokinetic study followed by a 28-day repeated daily dose study to establish the recommended phase 2 dose (RP2D). The first dose cohort will be treated at 3 mg/day; planned dose escalations are 6, 12, 24, and 48 mg/day, subject to observed safety assessments. In the third phase of the study, participants will be treated at the RP2D to confirm tolerability and assess preliminary evidence of efficacy.

In both the dose escalation and expansion cohorts, once the first 28 days of treatment and assessments are completed, at the discretion of the investigator a patient may continue to receive Cu(II)ATSM treatment for a maximum of six 28-day treatment cycles. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02870634
Study type Interventional
Source Collaborative Medicinal Development Pty Limited
Contact
Status Completed
Phase Phase 1
Start date November 16, 2016
Completion date January 30, 2020

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