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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2012-001313-16 |
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This is a study where AZD3241 or placebo is given to patients with Parkinson's disease in a blinded and randomized assignment. The main objective is to see if safety and tolerability of the drug is acceptable.
A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients with Parkinson's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3241, 300 mg | Active Comparator | AZD3241 300 mg BID |
|
| AZD3241, 600 mg | Active Comparator | AZD3241 600 mg BID |
|
| Placebo | Placebo Comparator | Placebo to AZD3241 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3241 300 mg BID | Drug | The following dose escalation schedule will be used for 300 mg BID: 100 mg BID from Day 1 through Day 7. On Day 8, the patients will start maintenance treatment of 300 mg BID for the duration of the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in vital signs. | Vital signs: systolic and diastolic blood pressure and pulse including orthostatic challenge will be assessed. Change from baseline at each visit will be calculated as the visit value minus the baseline value for each vital sign: Blood Pressure, pulse rate (supine and standing), weight and oral temperature. | Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) |
| Change from baseline in Physical Exam results. | Assessment of general appearance, skin, head and neck, lymph nodes, thyroid, abdomen, cardiovascular, respiratory, and neurological systems, including full palpation of thyroid gland. | Baseline and 2 weeks after termination of treatment (week 14) |
| Change from baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS). | Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS) The CSSRS assesses the suicidal behavior and suicidal ideation in patients. Occurrence of suicidal behavior is defined as having answered "yes" to a least 1 of the 4 suicidal behavior sub categories (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior) at any post randomization evaluation. Occurrence of suicidal ideation after randomization is defined as having answered "yes" to at least one of the suicidal ideation sub-categories (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods [not plan] without intent to act, active suicidal ideation with some intent to act [without specific plan], and active suicidal ideation with specific plan and intent) at any post randomization evaluation. | screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) |
| Adverse events (AEs) including frequency and severity. | Screening, randomization, week 1, 2, 4, 8, 12, 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of AZD3241 in the terms of Cmax, Cmin, and AUC0-t. | Blood samples (5 mL) for determination of AZD3241 concentration in plasma will be collected in accordance with the information in the Study Plan. PK analysis will be based on the PK analysis set. Plasma concentrations of AZD3241 will be determined and PK analyzed by a population PK model. PK analysis will be based on the PK analysis set and will include determination of observed Cmax, Cmin, and AUC0-t. Plasma drug concentrations of AZD3241 will be determined and PK analyzed by a population PK model. If the quality of the data does not allow a population PK analysis, plasma concentrations from all patients will be analyzed graphically and by descriptive statistics, as appropriate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Posener, MSD | AZ Neuro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| AZD3241 600 mg BID | Drug | The following dose escalation schedule will be used for 600 mg BID: 100 mg BID from Day 1 through Day 7 and 300 mg BID from Day 8 through Day 14. On Day 15, the patients will start maintenance treatment of 600 mg BID for the duration of the treatment period. |
|
| Placebo | Drug | Placebo to AZD3241 BID |
|
| Change from baseline in laboratory safety assessments. | Change from baseline at each visit will be calculated as the visit value minus the baseline value for each continuous clinical chemistry, hematology and urinalysis measurements. Abnormal or out-of-range values will be flagged. | Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) |
| Change from baseline in 12-lead ECG. | Change from baseline at each visit will be calculated as the visit value minus the baseline value for each ECG parameter: heart rate, QRS duration, PR interval, RR interval, QT and calculated QTcF interval. Abnormal or out-of-range values will be flagged. | Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) |
| Randomization and after week 1, 2, 4, 8, and 12 weeks of treatment |
| Pharmacodynamic effect of AZD3241 in the terms of Myeloperoxidase (MPO) activity in plasma. | Screening (baseline), randomization, after, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) |
| Long Beach |
| California |
| United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Atlantis | Florida | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Sunrise | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Kansas City | Kansas | United States |
| Research Site | Bingham Farms | Michigan | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Lawrenceville | New Jersey | United States |
| Research Site | Marlton | New Jersey | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C000602652 | AZD3241 |
| C494814 | BID protein, human |
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