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A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603069
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: AZD3241 300 mg BID Drug: AZD3241 600 mg BID Drug: Placebo Phase 2

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AZD3241, 300 mg
AZD3241 300 mg BID
 Drug: AZD3241 300 mg BID
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.
Active Comparator: AZD3241, 600 mg
AZD3241 600 mg BID
 Drug: AZD3241 600 mg BID
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 Comparator: Placebo
Placebo to AZD3241
 Drug: Placebo
Placebo to AZD3241 BID


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in vital signs. [ Time Frame: Screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) ]
    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.

  2. Change from baseline in Physical Exam results. [ Time Frame: Baseline and 2 weeks after termination of treatment (week 14) ]
    Assessment of general appearance, skin, head and neck, lymph nodes, thyroid, abdomen, cardiovascular, respiratory, and neurological systems, including full palpation of thyroid gland.

  3. Change from baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (CSSRS). [ Time Frame: screening (baseline), randomization, after 2, 4, 8 and 12 weeks of treatment and 2 weeks after termination of treatment (week 14) ]
    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.

  4. Adverse events (AEs) including frequency and severity. [ Time Frame: Screening, randomization, week 1, 2, 4, 8, 12, 14 ]
  5. Change from baseline in laboratory safety assessments. [ 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 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.


  6. Change from baseline in 12-lead ECG. [ 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 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.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AZD3241 in the terms of Cmax, Cmin, and AUC0-t. [ Time Frame: Randomization and after week 1, 2, 4, 8, and 12 weeks of treatment ]

    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.


  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each patient must be able and willing to provide signed and dated informed consent prior to the study.
  • Female and male patients aged 30 to 80 years at the day of enrollment (Visit 1).
  • Patients must meet the criteria for "Diagnosis of idiopathic Parkinson's disease" according to the UKPDS Brain Bank criteria (Hughes et al 1992).
  • Have a modified Hoehn and Yahr stage 1-2.5.
  • Having no treatment for Parkinson's disease and have no need to add anti-Parkinson's disease treatment during the 14 weeks of study OR are on stable anti-Parkinson's disease medication.

Exclusion Criteria:

  • 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.
  • Have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-Parkinson's disease conditions.
  • Presence of dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes, defined as scoring 2 or more on item 30 of the UPDRS.
  • Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e. bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
  • Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal (GI) disease, or other major disease as judged by the investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603069


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
Long Beach, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Florida
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
United States, Kansas
Research Site
Kansas City, Kansas, United States
United States, Michigan
Research Site
Bingham Farms, Michigan, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, New Jersey
Research Site
Lawrenceville, New Jersey, United States
Research Site
Marlton, New Jersey, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Joel Posener, MSD AZ Neuro
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01603069    
Other Study ID Numbers: D0490C00005
EudraCT number: 2012-001313-16
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013
Keywords provided by AstraZeneca:
Parkinson's disease
Safety
Tolerability
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases