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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581371 on ClinicalTrials.gov