A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
NCT ID: NCT01603069
Last Updated: 2013-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2012-10-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD3241, 300 mg
AZD3241 300 mg BID
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.
AZD3241, 600 mg
AZD3241 600 mg BID
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
Placebo to AZD3241
Placebo
Placebo to AZD3241 BID
Interventions
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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.
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
Placebo to AZD3241 BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Posener, MSD
Role: STUDY_DIRECTOR
AZ Neuro
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
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
Countries
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Other Identifiers
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EudraCT number: 2012-001313-16
Identifier Type: -
Identifier Source: secondary_id
D0490C00005
Identifier Type: -
Identifier Source: org_study_id
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