Parkinson's DiseasePhase 2NCT01527695
PET Study in Parkinson's Disease Patients
A Phase 2 study testing ER tablet 25 mg AZD3241 and ER tablet 100 mg AZD3241 in people with Parkinson's Disease, run by AstraZeneca at 3 sites in Sweden.
Trial summary
This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ER tablet 25 mg AZD3241 and ER tablet 100 mg AZD3241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesSweden
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 2
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)
- Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational
- The clinical diagnosis of patients must meet the criteria for "diagnosis of idiopathic Parkinson's disease" according to the modified UKPDS Brain Bank criteria (see Appendix E)
- Modified Hoehn and Yahr stage 1 to 2
Who cannot join
- Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases
- Patients who have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery
- Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist
- Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John's Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Reserach Site
Stockholm
Research Site
Uppsala
Research Site
Vällingby
About this study
Official title: A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease
This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.
Read the detailed description
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease
- Conditions
- Parkinson's Disease
- Being tested
- ER tablet 25 mg AZD3241, ER tablet 100 mg AZD3241, Placebo for AZD3241 25 mg, Placebo for AZD3241 100 mg
- Keywords
- Phase IIa, AZD3241, microglia activation, safety, Pharmacodynamics and pharmacokinetics analyses, Parkinson patients
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER tablet 25 mg AZD3241Drug
2 tablets twice daily for Day 1
ER tablet 100 mg AZD3241Drug
1-6 tablets twice daily from Day 2 until Day 56±3 days
Placebo for AZD3241 25 mgDrug
2 tablets twice daily for Day 1
Placebo for AZD3241 100 mgDrug
1-6 tablets twice daily from Day 2 until Day 56±3 days
| Study group | Role | What they receive |
|---|---|---|
| AZD3241 | Experimental | AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days Receives: Drug: ER tablet 25 mg AZD3241; Drug: ER tablet 100 mg AZD3241 |
| Placebo | Experimental | AZD3241 placebo bid for 8 weeks Receives: Drug: Placebo for AZD3241 25 mg; Drug: Placebo for AZD3241 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).
Measured: baseline, 2-4 weeks
Change of binding of [11C]PBR28 to TSPO measured by PET.
Measured: baseline, 7-8 weeks
Secondary outcomes (4)
Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.
Measured: Up to 10 weeks
Change in plasma activity of myeloperoxidase (MPO).
Measured: baseline, up to 10 weeks
Plasma concentrations of AZD3241.
Measured: Up to 8 weeks
Part of safety profile in terms of Columbia Suicide Severity Rating Scale.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Svenningsson, MD, PHD, Principal investigator, Karolinska University HospitalBjorn Paulsson, MD, Study director, AstraZeneca Medical Science Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527695
- Sponsor's protocol ID
- D0490C00004
- Status last verified
- Jan 2013
- First submitted
- 22 Dec 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01527695
- Acronym / sponsor ID
- D0490C00004
- Conditions
- Parkinson's Disease
- Keywords
- Phase IIa, AZD3241, microglia activation, safety, Pharmacodynamics and pharmacokinetics analyses, Parkinson patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Feb 2012 (estimated)
- 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.
This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.
Detailed description
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD3241 | Experimental | Drug: ER tablet 25 mg AZD3241, Drug: ER tablet 100 mg AZD3241AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days |
| Placebo | Experimental | Drug: Placebo for AZD3241 25 mg, Drug: Placebo for AZD3241 100 mgAZD3241 placebo bid for 8 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)
- Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational
- The clinical diagnosis of patients must meet the criteria for "diagnosis of idiopathic Parkinson's disease" according to the modified UKPDS Brain Bank criteria (see Appendix E)
- Modified Hoehn and Yahr stage 1 to 2
Key exclusion criteria (4 listed)
- Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases
- Patients who have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery
- Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist
- Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John's Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;
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 |
|---|---|---|
| ER tablet 25 mg AZD32412 tablets twice daily for Day 1 | Drug | AZD3241 |
| ER tablet 100 mg AZD32411-6 tablets twice daily from Day 2 until Day 56±3 days | Drug | AZD3241 |
| Placebo for AZD3241 25 mg2 tablets twice daily for Day 1 | Drug | Placebo |
| Placebo for AZD3241 100 mg1-6 tablets twice daily from Day 2 until Day 56±3 days | Drug | Placebo |
Primary outcome
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).
Time frame: baseline, 2-4 weeks
Change of binding of [11C]PBR28 to TSPO measured by PET.
Time frame: baseline, 7-8 weeks
4 secondary outcomes
Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.
Time frame: Up to 10 weeks
Change in plasma activity of myeloperoxidase (MPO).
Time frame: baseline, up to 10 weeks
Plasma concentrations of AZD3241.
Time frame: Up to 8 weeks
Part of safety profile in terms of Columbia Suicide Severity Rating Scale.
Time frame: Up to 10 weeks
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 31 Jan 2013.
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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.
Per Svenningsson, MD, PHD principal investigator
Karolinska University Hospital
Bjorn Paulsson, MD study director
AstraZeneca Medical Science Director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ER tablet 25 mg AZD3241 and ER tablet 100 mg AZD3241 in people with Parkinson's Disease, run by AstraZeneca at 3 sites in Sweden.
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 5 inclusion and 4 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET). (time frame: baseline, 2-4 weeks). The study lists 2 primary outcomes in all. 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 31 Jan 2013.