Status:
COMPLETED
PET Study in Parkinson's Disease Patients
Lead Sponsor:
AstraZeneca
Conditions:
Parkinson's Disease
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkin...
Detailed Description
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positr...
Eligibility Criteria
Inclusion
- Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)
- Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational
- The clinical diagnosis of patients must meet the criteria for "diagnosis of idiopathic Parkinson's disease" according to the modified UKPDS Brain Bank criteria (see Appendix E)
- Modified Hoehn and Yahr stage 1 to 2
Exclusion
- 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
- Patients who have undergone surgery for the treatment of Parkinson's disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery
- Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist
- Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John's Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01527695
Start Date
April 1 2012
End Date
January 1 2013
Last Update
January 31 2013
Active Locations (3)
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1
Reserach Site
Stockholm, Sweden
2
Research Site
Uppsala, Sweden
3
Research Site
Vällingby, Sweden