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Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03204929•Collaborative Medicinal Development Pty Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent prior to initiation of any study-specific procedures
•Early idiopathic Parkinson's disease (PD) with at least two of the cardinal signs of PD (resting tremor, bradykinesia, rigidity, postural instability). If tremor is not present, must have unilateral onset and persistent asymmetry of symptoms.
•Hoehn \& Yahr stage ≤ 2
•First PD motor symptoms occurred ≤ 5 years prior to screening visit
•Use of dopaminergic therapy allowed provided dose is stable for at least 8 weeks prior to screening visit
•Use of amantadine and/or anticholinergics allowed provided dose is stable for at least 8 weeks prior to screening visit
•Use of CNS-acting medications allowed provided dose is stable for at least 4 weeks prior to screening visit
•Age ≥ 30 years at time of PD diagnosis
•Adequate bone marrow reserve, liver and renal function:
•Absolute neutrophil count ≥ 1500/µL; Platelet count ≥ 150,000/µL; Hemoglobin ≥ 11 g/dL; Creatinine clearance ≥ 6- mL/min (Cockroft \& Gault formula); ALT and/or AST ≤ 2 x ULN; total bilirubin ≤ 1.5 x ULN; albumin ≥ 2.8 g/dL
+1 more criteria

Exclusion Criteria

•Atypical Parkinsonism
•Taking ≥ 3 dopaminergic medications
•Exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to screening visit
•Exposure to any other investigational agent within 6 months or 2 investigational agents within 12 months prior to screening visit
•Known immune compromising illness or treatment
•History of brain surgery for PD, including deep brain stimulation and stem cell transplants
•History of cognitive or neuropsychiatric conditions
•Inability to swallow oral medications or presence of a GI disorder (eg, malabsorption) deemed to jeopardize intestinal absorption of study drug
•Active GI disease (excluding GERD) within 30 days prior to screening visit
•Presence of any of the following clinical conditions:
+2 more criteria

Locations (2)

Macquarie University

Macquarie Park, New South Wales, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

August 14, 2017

Primary Completion Date

November 30, 2019

Completion Date

February 29, 2020

Last Updated

March 17, 2020

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Cu(II)ATSM

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations