A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease
NCT01603069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2013-07-19
Summary
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.
Conditions
Interventions
- 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.
- 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.
- DRUG
-
Placebo to AZD3241 BID
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Joel Posener, MSD · AZ Neuro
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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