Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
NCT02581371 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2015-10-21
Summary
The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke.
Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.
Conditions
Interventions
- DRUG
-
Cerebrolysin infusion
Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
- OTHER
-
Placebo infusion
Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval
Sponsors & Collaborators
-
Clinical Institute of the Brain, Russia
lead OTHER
Principal Investigators
-
Andrey Avgustovich Belkin, Prof.,MD,PhD · Clinical Institute of Brain
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- Russia
Study Locations
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