Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson's Disease
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects are randomised to one of two groups within a cohort of 12 subjects (N=9 MEDI1341; N=3 Placebo)Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 85 years
- Gender
- Both males and females
Description
The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects. The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of M...
The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects. The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between infusions. The overall study duration (enrolment, treatment, and follow-up periods) will be up to 28 weeks per subject. A Dose Escalation Committee will review data from each cohort to allow progression to the next higher dose cohort in the study.
Tracking Information
- NCT #
- NCT04449484
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Beth E. Safirstein, MD MD Clinical
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