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 |
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.
We found this trial at
10
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials