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
-
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
Location
Location
Omaha, Nebraska, United States
Location
Sunrise, Florida, United States
Location
Bingham Farms, Michigan, United States
Location
Atlantis, Florida, United States
Location
Tampa, Florida, United States
Location
Boca Raton, Florida, United States
Location
Kansas City, Kansas, United States
Location
Marlton, New Jersey, United States
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 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.