Study identifier:D0490C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Parkinson's disease
Phase 2
No
AZD3241 300 mg BID, AZD3241 600 mg BID, Placebo
All
51
Interventional
30 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jul 2013 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
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 |