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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03204929




Registration number
NCT03204929
Ethics application status
Date submitted
28/06/2017
Date registered
2/07/2017

Titles & IDs
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
Secondary ID [1] 0 0
CMD-2016-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cu(II)ATSM

Experimental: Cu(II)ATSM - Cu(II)ATSM dosed once daily


Treatment: Drugs: Cu(II)ATSM
copper-containing synthetic small molecule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended phase 2 dose
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Treatment-related changes in disease severity
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Treatment-related changes in motor function
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Treatment-related changes in cognitive function
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Treatment-related changes in quality of life
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Treatment-related changes in constipation
Timepoint [5] 0 0
6 months

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/02/2020
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Collaborative Medicinal Development Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Evans, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Plan to publish trial results and post results on www.ClinicalTrials.gov
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03204929