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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 2012
End Date:September 2013
Contact:AstraZeneca Clinical Study Information
Email:information.center@astrazeneca.com
Phone:800-236-9933

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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


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

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.
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