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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
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.
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 to AZD3241 BID
Research Site
Birmingham, Alabama, United States
Research Site
Long Beach, California, United States
Research Site
New Haven, Connecticut, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening, randomization, week 1, 2, 4, 8, 12, 14
Change from baseline in laboratory safety assessments.
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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
...and 3 more locations
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.
Time frame: 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.
Time frame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)
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.
Time frame: 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.
Time frame: Screening (baseline), randomization, after, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14)