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

NCT03204929 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CMD-2016-002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

Multicenter, open-label dose-escalation study

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Recommended phase 2 dose

  Recommended phase 2 dose as determined by the number of patients in each dose cohort with intolerance over up to six months treatment

  6 months

Secondary Outcomes (5)

• Treatment-related changes in disease severity

  6 months

• Treatment-related changes in motor function

  6 months

• Treatment-related changes in cognitive function

  6 months

• Treatment-related changes in quality of life

  6 months

• Treatment-related changes in constipation

  6 months

Study Arms (1)

Cu(II)ATSM

EXPERIMENTAL

Cu(II)ATSM dosed once daily

Drug: Cu(II)ATSM

Interventions

Cu(II)ATSM DRUG

copper-containing synthetic small molecule

Also known as: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)

Cu(II)ATSM

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collaborative Medicinal Development Pty Limited: lead

Study Sites (2)

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

copper (II) diacetyl-di(N(4)-methylthiosemicarbazone); Copper

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Andrew Evans, MD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: August 14, 2017
• Primary Completion: November 30, 2019
• Study Completion: February 29, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (2)