Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease
Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study
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.
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