Parkinson DiseasePhase 1NCT03204929
Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease
A Phase 1 study testing Cu(II)ATSM in people with Parkinson Disease, run by Collaborative Medicinal Development Pty Limited at 2 sites in Australia.
Trial summary
Multicenter, open-label dose-escalation study Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cu(II)ATSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesAustralia
- Study dates
- 14 Aug 2017to 29 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Macquarie University
Macquarie Park, New South Wales, 2109
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
About this study
Official title: A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease
Multicenter, open-label dose-escalation study
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Cu(II)ATSM
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu(II)ATSMDrug
Also called diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
copper-containing synthetic small molecule
| Study group | Role | What they receive |
|---|---|---|
| Cu(II)ATSM | Experimental | Cu(II)ATSM dosed once daily Receives: Drug: Cu(II)ATSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
Treatment-related changes in disease severity
Treatment-related changes in disease severity assessed by the Unified Parkinson Disease Rating Scale (UPDRS)
Measured: 6 months
Treatment-related changes in motor function
Treatment related changes in motor function assessed by the UPDRS Part III score and UPDRS ambulatory capacity subscore
Measured: 6 months
Treatment-related changes in cognitive function
Treatment related changes in cognitive function assessed by the Montreal Cognitive Assessments (MoCA)
Measured: 6 months
Treatment-related changes in quality of life
Treatment related changes in quality of life assessed by the 39-item Parkinson Disease Questionnaire (PDQ-39)
Measured: 6 months
Treatment-related changes in constipation
Treatment related changes in constipation assessed by the Wexler Constipation Score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start14 Aug 2017
- Primary completion30 Nov 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collaborative Medicinal Development Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Evans, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204929
- Sponsor's protocol ID
- CMD-2016-002
- Status last verified
- Mar 2020
- First submitted
- 28 Jun 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to publish trial results and post results on www.ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03204929
- Acronym / sponsor ID
- CMD-2016-002
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Collaborative Medicinal Development Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cu(II)ATSM | Experimental | Drug: Cu(II)ATSMCu(II)ATSM dosed once daily |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cu(II)ATSMAlso: diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)copper-containing synthetic small molecule | Drug | Cu(II)ATSM |
Primary outcome
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
5 secondary outcomes
Treatment-related changes in disease severity
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 quality of life
Time frame: 6 months
Treatment-related changes in constipation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Yes. Plan to publish trial results and post results on www.ClinicalTrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Evans, MD principal investigator
Melbourne Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cu(II)ATSM in people with Parkinson Disease, run by Collaborative Medicinal Development Pty Limited at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase 2 dose (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.