NCT03204929

Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease

A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Collaborative Medicinal Development Pty Limited · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label dose-escalation study

Detailed description

Multicenter, open-label, phase 1 study of Cu(II)ATSM administered orally to patients with early idiopathic Parkinson's disease. The study will be conducted in two phases. In the first phase, dose cohorts of six patients each will receive escalating daily doses of Cu(II)ATSM to establish the recommended phase 2 dose (RP2D). The starting dose will be 12 mg/day, which has been shown to be well tolerated in an ongoing phase 1 pharmacokinetic and dose-finding study of Cu(II)ATSM in patients with ALS (ClinicalTrials.gov identifier NCT02870634). In the second phase of the study, an expansion cohort of 20 patients 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 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Cu(II)ATSM	copper-containing synthetic small molecule

Timeline

• Start date: 2017-08-14
• Primary completion: 2019-11-30
• Completion: 2020-02-29
• First posted: 2017-07-02
• Last updated: 2020-03-17

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study