Multiple System Atrophy, MSAPhase 2NCT02388295
AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients
A Phase 2 study testing AZD3241 in people with Multiple System Atrophy, MSA, run by AstraZeneca at 17 sites in 7 countries.
Trial summary
AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability, randomized trial, in patients with Multiple System Atrophy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple System Atrophy, MSA
- What is being tested?
- AZD3241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 27 Apr 2015to 19 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 30-80 years, inclusive, at screen.
- Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008 ).
- "High-affinity binder" or "mixed-affinity binder" for TSPO, as confirmed by prospective genotyping of TSPO polymorphism during screen.
- Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. The informed consent should reflect the protocol stipulations concerning the use of contraception.
- Medical treatment of MSA and co-morbid medical conditions must be stable for at least 30 days prior to screen and between screen and baseline.
- Written and oral fluency in the local language.
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- Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
- In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
- Able to swallow tablets whole.
Who cannot join
- Prior participation in any AZD3241 study.
- Magnetic resonance imaging (MRI) performed during screen not consistent with diagnosis of MSA.
- Received a PET scan within the last 12 months.
- Negative Allen test in both hands, unless the brachial artery is used for arterial cannulation.
- Subjects determined to be "low affinity binders" by TSPO genotyping.
- Claustrophobia that would contraindicate a brain MRI scan or brain PET scan.
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- Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screen or positive urine β-hCG at baseline (Day -1).
- Initiation or change in pharmacologic therapy for symptoms of MSA within 30 days prior to screen or between screen and baseline (Day -1).
- Significant neurological disease affecting the central nervous system (CNS), other than MSA
- History of brain surgery for parkinsonism.
- History of stem cell treatment.
- Seizure disorder, unless well controlled and for which treatment has been stable for at least 30 days prior to screen and between screen and baseline (Day -1).
- Presence of any clinically significant medical condition
- History or presence of thyroid disease.
- Any abnormal TSH or Free T4 test result at screen or baseline (Day -1).
- History or presence of gastrointestinal disorders or other disease known to interfere with absorption, distribution, metabolism or excretion of drugs
- History or presence of renal disease or impaired renal function.
- A QT interval corrected according to the Fridericia procedure (QTcF) interval measurement > 450 msec at screen (single ECG) or baseline (Day -1) (mean of three ECG measurements) or a family history of long-QT syndrome.
- Uncontrolled hypertension
- History or presence of diabetes, unless glucose levels have been well controlled and for which treatment has been stable for at least 30 days prior to screen and between screen and baseline (Day -1).
- History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin.
- Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.
- Use of potent inhibitors of CYP3A4, Use of potent inducers of CYP3A4 and/or Use of drugs mainly metabolized by CYP3A4
- Treatment with any investigational drug or device within 60 days or five half-lives prior to screen, whichever is longer, or between screen and baseline (Day -1).
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States8 sites
Research Site
Ann Arbor, Michigan, 48105-2945
Research Site
Boston, Massachusetts, 02215
Research Site
New Haven, Connecticut, 06520-8048
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
Rochester, Minnesota, 55905
Research Site
Stanford, California, 94305
Research Site
Tampa, Florida, 33613
United Kingdom3 sites
Research Site
London, SE5 9RJ
Research Site
London, W12 0NN
Research Site
Oxford, OX3 9DU
About this study
Official title: A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects With Multiple System Atrophy
AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability, randomized trial, in patients with Multiple System Atrophy.
- Conditions
- Multiple System Atrophy, MSA
- Being tested
- AZD3241, Placebo
- Keywords
- Multiple System Atrophy (MSA), PET imaging, myeloperoxidase (MPO) inhibitor
- Medical subject headings
- Multiple System Atrophy, Thyroid Dyshormonogenesis 2A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3241Drug
Also called AZD3241 to match placebo administered for 12 weeks.
Drug: AZD3241 administered for 12 weeks orally as a tablet.
PlaceboDrug
Also called Placebo to match AZD3241 administered for 12 weeks.
Placebo to match AZD3241 administered for 12 weeks orally as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| AZD3241 | Experimental | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. Receives: Drug: AZD3241 |
| Placebo to match AZD3241 | Placebo comparator | Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)
Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein
Measured: Baseline (pre randomization) and Week 12
Secondary outcomes (1)
Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity
Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein)
Measured: Baseline (Day -1) and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start27 Apr 2015
- Primary completion19 Sep 2016
- Study completion19 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple System Atrophy, MSAStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388295
- Sponsor's protocol ID
- D0490C00023
- Status last verified
- Jul 2017
- First submitted
- 9 Mar 2015
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT02388295
- Acronym / sponsor ID
- D0490C00023
- Conditions
- Multiple System Atrophy, MSA
- Keywords
- Multiple System Atrophy (MSA), PET imaging, myeloperoxidase (MPO) inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 19 Sep 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AZD3241 myeloperoxidase (MPO) inhibitor trial is assessing safety and tolerability, randomized trial, in patients with Multiple System Atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD3241 | Experimental | Drug: AZD3241Subjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
| Placebo to match AZD3241 | Placebo comparator | Drug: PlaceboSubjects will be randomized to one of the two doses of AZD3241 or placebo in a 1:1:1 ratio. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age 30-80 years, inclusive, at screen.
- Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008 ).
- "High-affinity binder" or "mixed-affinity binder" for TSPO, as confirmed by prospective genotyping of TSPO polymorphism during screen.
- Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. The informed consent should reflect the protocol stipulations concerning the use of contraception.
- Medical treatment of MSA and co-morbid medical conditions must be stable for at least 30 days prior to screen and between screen and baseline.
Key exclusion criteria (24 listed)
- Prior participation in any AZD3241 study.
- Magnetic resonance imaging (MRI) performed during screen not consistent with diagnosis of MSA.
- Received a PET scan within the last 12 months.
- Negative Allen test in both hands, unless the brachial artery is used for arterial cannulation.
- Subjects determined to be "low affinity binders" by TSPO genotyping.
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 |
|---|---|---|
| AZD3241Also: AZD3241 to match placebo administered for 12 weeks.Drug: AZD3241 administered for 12 weeks orally as a tablet. | Drug | AZD3241 |
| PlaceboAlso: Placebo to match AZD3241 administered for 12 weeks.Placebo to match AZD3241 administered for 12 weeks orally as a tablet. | Drug | Placebo to match AZD3241 |
Primary outcome
Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)
Time frame: Baseline (pre randomization) and Week 12
Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein
1 secondary outcome
Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity
Time frame: Baseline (Day -1) and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD3241 in people with Multiple System Atrophy, MSA, run by AstraZeneca at 17 sites in 7 countries.
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 9 inclusion and 24 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom, France, Austria, Finland and 2 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) (time frame: Baseline (pre randomization) and Week 12). 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 25 Sep 2017.