NCT02581371

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 19, 2015

Last Update Submit

October 19, 2015

Conditions

Ischemic Stroke

Keywords

Cerebrolysinneuroplasticityupper limbmiddle cerebral arteryNBSnavigation brain stimulationparetic limbstrokeischemic strokerehabilitationFrenchay Arm TestNBS eXimia NexstimBarthel index

Outcome Measures

Primary Outcomes (1)

  • Overall dynamics of the hand function assessed by the Frenchay Arm Test

    Visit 5 data comparison with Visit 0 data

    6 months

Secondary Outcomes (10)

  • Dynamics of the hand function assessed by the Frenchay Arm Test

    6 months

  • Dynamics of the grades on the NIHSS scale

    6 months

  • Dynamics of the grades on the modified Rankin scale

    6 months

  • Dynamics of the Barthel index changes

    6 months

  • Dynamics of the cerebral infarction volume decrease according the 3D MRI data

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Cerebrolysin infusion

EXPERIMENTAL

Cerebrolysin, solution for injection, 10 ml vials. 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

Drug: Cerebrolysin infusion

Placebo infusion

PLACEBO COMPARATOR

Sodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval.

Other: Placebo infusion

Interventions

Cerebrolysin infusionDRUG

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

Also known as: Cerebrolysin
Cerebrolysin infusion
Placebo infusionOTHER

Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval

Also known as: sodium chloride
Placebo infusion

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A signed patient informed consent;
  • Men and women at the age from 45 years to 75 years, inclusive;
  • Confirmed (clinically and by MRI of the brain) diagnosis of acute ischemic stroke in the basin of the middle cerebral artery;
  • The severity of the stroke from 5 to 24 points on a scale NIHSS;
  • Hemiparesis, mainly affecting the upper limbs (not more than 2 points in the evaluation function of the affected hand using the test for hand Frenchay and not more than 2 points in the evaluation of the affected lower limb 6-point scale NIHSS);
  • The time from the onset of the disease prior to the introduction of the drug for 72 hours;

You may not qualify if:

  • The age of 45 years or older than 75 years;
  • Known intolerance (including allergic reactions) Cerebrolysin, excipients of the investigational medication;
  • Thrombolytic therapy;
  • Signs of a hemorrhagic stroke;
  • Impairment of consciousness (≥ 2 points during the evaluation under item 1A NIHSS);
  • The presence of elements allowing to predict the resolution of neurological symptoms within 24 hours from the first symptoms;
  • Stroke or transient ischemic attack in history;
  • The score on the modified Rankin scale to a stroke more than 0 points;
  • Concomitant therapy or neuroprotective nootropic drugs;
  • New-onset seizures or epilepsy;
  • Planned carotid endarterectomy or other operations for secondary prevention of stroke;
  • Neurological disease or pathology of the neuromuscular system or any other disease that may affect the interpretation of study results;
  • Systemic therapy with biological drugs, including interferon, inductors and/or cytokine/anti-cytokine (e.g., anti-TNF, anti-CD4, IL-10, IL-1, etc.) within 1 month prior to screening;
  • Severe concomitant diseases, including cancer, which, in the opinion of the investigator, may affect the estimated parameters;
  • Uncontrolled hypertension (SBP ≥ 220 mm Hg. CL. and/or DBP ≥ 120 mm Hg. article in repeated measurements at the screening visit);
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Institute of Brain

Beryozovsky, Sverdlovsk Oblast, 620102, Russia

RECRUITING

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

RECRUITING

Related Links

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

cerebrolysinSodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Andrey Avgustovich Belkin, Prof.,MD,PhD

    Clinical Institute of Brain

    STUDY DIRECTOR

Central Study Contacts

Andrey Avgustovich Belkin, Prof.,MD,PhD

CONTACT

(343) 311-3381clinic@neuro-clinic.ru

Andrey Marisovich Alasheev, MD, PhD

CONTACT

(343) 351-1535director@sciencefiles.ru

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 21, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

RU(2)