Cerebrolysin and Recovery after Stroke (CARS) - A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase II Clinical Study. - CERE-REHA-1

Phase 1

Conditions: Recovery after Stroke
MedDRA version: 12.0Level: LLTClassification code 10055221Term: Ischemic stroke

Registration Number: EUCTR2007-000870-21-PL

Lead Sponsor: EVER Neuro Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 236

Inclusion Criteria

- stroke onset 24-72 hours prior to first infusion of study drug
- stroke is ischemic in origin, supratentorial, radiologically confirmed (CT or MRI) and has volume > 4 cc
- age between 18-80 years inclusive
- no significant pre-stroke disability (pre-stroke Modified Rankin Score of 0 or 1)
- no other stroke in 3 months preceding index stroke
- Action Research Arm Test Score < 50 (corresponding to the half of the body showing hemiparesis)
- a score of >2 in the Goodglass and Kaplan Communication Scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- progresive or unstable stroke
- pre-existing and active major neurological disease
- pre-existing and active (e.g. on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia
- a history of significant alcohol or drug abuse in the prior 3 years
- advanced liver, kidney, cardiac or pulmonary disease
- a terminal medical diagnosis consistent with survival < 1 year
- substantial decrease in alertness at time of randomization, defined as score of 2 on NIH stroke scale question 1a, 1b or 1c
- pregnancy or lactating; note that a negative pregnancy test will be required if the patient is female in reproductive years
- any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
- current enrolment in another therapeutic study of stroke or stroke recovery