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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03204929
• Date of registration: 28/06/2017
• Prospective Registration: Yes
• Primary sponsor: Collaborative Medicinal Development Pty Limited
• Public title: Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease
• Scientific title: A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease
• Date of first enrolment: August 14, 2017
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03204929
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Andrew Evans, MD
• Affiliation: Melbourne Health

Key inclusion & exclusion criteria

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

- Women and men with partners of childbearing potential must take effective
contraception while on study and women of childbearing potential must have a negative
pregnancy test and be non-lactating at screening

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:

any significant non-PD CNS disorder; drug abuse or alcoholism; unstable cardiac, pulmonary,
renal, hepatic, endocrine or hematologic disease; active infectious disease; AIDS or
AIDS-related complex; malignancy within 3 years of screening (other than fully excised
non-melanoma skin cancer, cured in situ cervical carcinoma, early stage bladder cancer, or
DCIS of breast); psychosis or untreated major depression within 30 days of screening;
dementia

- Current use of strong inducers or inhibitors of CYPs 2C19 and 2D6



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Cu(II)ATSM

Primary Outcome(s)

Recommended phase 2 dose [Time Frame: 6 months]

Secondary Outcome(s)

Treatment-related changes in quality of life [Time Frame: 6 months]

Treatment-related changes in constipation [Time Frame: 6 months]

Treatment-related changes in motor function [Time Frame: 6 months]

Treatment-related changes in cognitive function [Time Frame: 6 months]

Treatment-related changes in disease severity [Time Frame: 6 months]

Secondary ID(s)

CMD-2016-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors