Trial · NCT02388295
AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients
NCT02388295, Phase 2, Completed, AstraZeneca; results first posted 2017-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients. Trials, record NCT02388295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02388295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients
- NCT number
- NCT02388295
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Multiple System Atrophy, MSA
- Interventions
- AZD3241, Placebo
- First posted
- 2015-03-17
- Last updated
- 2017-09-25
- Results first posted
- 2017-09-25
- Limitations and caveats
Biomarker samples were included if testing done within 6 months of collection, recommendation changed to 3 months of collection during study. Included based on 6 months as per protocol to include as many samples as possible.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) | Baseline (pre randomization) and Week 12 | Striatum Brain region: Change from baseline in microglia activation via PET By \[11C\]PBR28 binding to translocator protein |
| Secondary | Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | Baseline (Day -1) and week 12 | Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein) |
| Other | Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2) | Baseline to final treatment visit | Exploratory efficacy: Unified Multiple System Atropy Rating Scale, change from baseline (total Score, Part 1 + Part 2) : Score range 0 to 104, positive value indicates worsening symptoms |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) | Baseline (pre randomization) and Week 12 | PET analysis population (Paired baseline and week 12 PET scans) | ml/cc | MEAN |
| SECONDARY | Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | Baseline (Day -1) and week 12 | efficacy population, restricted to subjects with paired samples analyzed within 6 months of collection | ratio | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2) | Baseline to final treatment visit | Efficacy population: with baseline (Day -1) and post baseline assessment | Score change from baseline | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) | Placebo | -0.23 | Standard Deviation 0.61 | ml/cc | |
| Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) | AZD3241 300 mg | 0.12 | Standard Deviation 0.83 | ml/cc | |
| Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET) | AZD3241 600 mg | -0.35 | Standard Deviation 1.25 | ml/cc | |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | Placebo | Pre dose (week 12) | 0.12 | 90% Confidence Interval -0.10 to 0.50 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | AZD3241 300 mg | Pre dose (week 12) | -0.12 | 90% Confidence Interval -0.22 to -0.03 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | AZD3241 600 mg | Pre dose (week 12) | -0.12 | 90% Confidence Interval -0.18 to -0.05 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | Placebo | 1 hour post dose (WEEK 12 | 0.12 | 90% Confidence Interval -0.30 to 0.54 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | AZD3241 300 mg | 1 hour post dose (WEEK 12 | -0.10 | 90% Confidence Interval -0.58 to 0.39 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | AZD3241 600 mg | 1 hour post dose (WEEK 12 | 0.10 | 90% Confidence Interval -0.27 to 0.48 | ratio |
| Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity | Placebo | 2 to 6 hours post dose (week 12) | 0.04 | 90% Confidence Interval -0.04 to 0.13 | ratio |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Week 1 | STARTED | Placebo | 19 | |
| Dose Escalation Week 1 | STARTED | AZD3241 300 mg | 19 | |
| Dose Escalation Week 1 | STARTED | AZD3241 600 mg | 20 | |
| Dose Escalation Week 1 | COMPLETED | Placebo | 17 | |
| Dose Escalation Week 1 | COMPLETED | AZD3241 300 mg | 16 | |
| Dose Escalation Week 1 | COMPLETED | AZD3241 600 mg | 18 | |
| Dose Escalation Week 1 | NOT COMPLETED | Placebo | 2 | |
| Dose Escalation Week 1 | NOT COMPLETED | AZD3241 300 mg | 3 | |
| Dose Escalation Week 1 | NOT COMPLETED | AZD3241 600 mg | 2 | |
| Dose Escalation Week 2 | STARTED | Placebo | 17 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | atrial fibrilation | Cardiac disorders | Placebo | 0 | 19 | 0 |
| other | atrial fibrilation | Cardiac disorders | AZD3241 300 mg | 0 | 19 | 0 |
| other | atrial fibrilation | Cardiac disorders | AZD3241 600 mg | 1 | 20 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 19 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | AZD3241 300 mg | 0 | 19 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | AZD3241 600 mg | 0 | 20 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 19 | 0 |
| other | Vertigo | Ear and labyrinth disorders | AZD3241 300 mg | 1 | 19 | 1 |
| other | Vertigo | Ear and labyrinth disorders | AZD3241 600 mg | 1 | 20 | 1 |
| other | Diplopia | Eye disorders | Placebo | 0 | 19 | 0 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | AZD3241 300 mg | ||
| Total, all-cause mortality | AZD3241 600 mg | ||
| Total, other adverse events | Placebo | 14 | 19 |
| Total, other adverse events | AZD3241 300 mg | 15 | 19 |
| Total, other adverse events | AZD3241 600 mg | 15 | 20 |
| Total, serious adverse events | Placebo | 1 | 19 |
| Total, serious adverse events | AZD3241 300 mg | 1 | 19 |
| Total, serious adverse events | AZD3241 600 mg | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02388295
GET https://conductscience.org/api/trials/v1/NCT02388295/flow?page=2