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

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ClinicalTrials.gov Identifier: NCT03204929
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Collaborative Medicinal Development Pty Limited

Brief Summary:
Multicenter, open-label dose-escalation study

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Cu(II)ATSM Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cu(II)ATSM
Cu(II)ATSM dosed once daily
Drug: Cu(II)ATSM
copper-containing synthetic small molecule
Other Name: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)



Primary Outcome Measures :
  1. Recommended phase 2 dose [ Time Frame: 6 months ]
    Recommended phase 2 dose as determined by the number of patients in each dose cohort with intolerance over up to six months treatment


Secondary Outcome Measures :
  1. Treatment-related changes in disease severity [ Time Frame: 6 months ]
    Treatment-related changes in disease severity assessed by the Unified Parkinson Disease Rating Scale (UPDRS)

  2. Treatment-related changes in motor function [ Time Frame: 6 months ]
    Treatment related changes in motor function assessed by the UPDRS Part III score and UPDRS ambulatory capacity subscore

  3. Treatment-related changes in cognitive function [ Time Frame: 6 months ]
    Treatment related changes in cognitive function assessed by the Montreal Cognitive Assessments (MoCA)

  4. Treatment-related changes in quality of life [ Time Frame: 6 months ]
    Treatment related changes in quality of life assessed by the 39-item Parkinson Disease Questionnaire (PDQ-39)

  5. Treatment-related changes in constipation [ Time Frame: 6 months ]
    Treatment related changes in constipation assessed by the Wexler Constipation Score



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204929


Contacts
Contact: Kay Noel, PhD 415 444 9602 kay.noel@ColMedDev.com
Contact: Craig Rosenfeld, MD 415 444 9602 CraigR@ColMedDev.com

Locations
Australia, New South Wales
Macquarie University Recruiting
Macquarie Park, New South Wales, Australia, 2109
Contact: Dominic Rowe, MD       Dominic.Rowe@mq.edu.au   
Australia, Victoria
The Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Andrew Evans, MD       Andrew.Evans@mh.org.au   
Sponsors and Collaborators
Collaborative Medicinal Development Pty Limited
Investigators
Principal Investigator: Andrew Evans, MD Melbourne Health

Responsible Party: Collaborative Medicinal Development Pty Limited
ClinicalTrials.gov Identifier: NCT03204929     History of Changes
Other Study ID Numbers: CMD-2016-002
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to publish trial results and post results on www.ClinicalTrials.gov

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs