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Trial · Interventional

Status unknownPhase 4Registry data

Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
Clinical Institute of the Brain, Russia · Other
Design
Randomized · Double masking
Countries
1 country

Russia

Start
Feb 2015
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
First posted
21 Oct 2015 (estimated)
Last update posted
21 Oct 2015 (estimated)
Conditions
Ischemic Stroke

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm

    NCT02581371

    Feb 2015 to est. Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Cerebrolysin infusionDrug
  • Placebo infusionOther

Arms2

  • Experimental

    Cerebrolysin infusion

    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

  • Placebo comparator

    Placebo infusion

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall dynamics of the hand function assessed by the Frenchay Arm Test

    Time frame · 6 months

    Registry description

    Visit 5 data comparison with Visit 0 data

Secondary outcomes(10)
  1. Dynamics of the hand function assessed by the Frenchay Arm Test

    Time frame · 6 months

    Registry description

    Visits 2,3,4 data comparison with Visit 0 data

  2. Dynamics of the grades on the NIHSS scale

    Time frame · 6 months

    Registry description

    Visits 2,3,4,5 data comparison with Visit 0 data

  3. Dynamics of the grades on the modified Rankin scale

    Time frame · 6 months

    Registry description

    Visits 2,3,4,5 data comparison with Visit 0 data

  4. Dynamics of the Barthel index changes

    Time frame · 6 months

    Registry description

    Visits 2,3,4,5 data comparison with Visit 0 data

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

    Time frame · 6 months

  6. Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)

    Time frame · 6 months

    Registry description

    Visit 4, 5 data comparison with Visit 3 data

  7. Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)

    Time frame · 6 months

  8. Dynamics of the amplitude of motor responses

    Time frame · 6 months

  9. Dynamics of the latency of motor responses

    Time frame · 6 months

  10. Frequency, nature and severity of adverse events.

    Time frame · 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: 1. A signed patient informed consent; 2. Men and women at the age from 45 years to 75 years, inclusive; 3. Confirmed (clinically and by MRI of the brain) diagnosis of acute ischemic stroke in the basin of the middle cerebral artery; 4. The severity of the stroke from 5 to 24 points on a scale NIHSS; 5. 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); 6. The time from the onset of the disease prior to the introduction of the drug for 72 hours; 7. The willingness of patients of both sexes and their sexual partners with preserved reproductive function to use reliable methods of contraception, starting from the moment of inclusion in the study until the completion of participation in this clinical study. Exclusion Criteria: 1. The age of 45 years or older than 75 years; 2. Known intolerance (including allergic reactions) Cerebrolysin, excipients of the investigational medication; 3. Thrombolytic therapy; 4. Signs of a hemorrhagic stroke; 5. Impairment of consciousness (≥ 2 points during the evaluation under item 1A NIHSS); 6. The presence of elements allowing to predict the resolution of neurological symptoms within 24 hours from the first symptoms; 7. Stroke or transient ischemic attack in history; 8. The score on the modified Rankin scale to a stroke more than 0 points; 9. Concomitant therapy or neuroprotective nootropic drugs; 10. New-onset seizures or epilepsy; 11. Planned carotid endarterectomy or other operations for secondary prevention of stroke; 12. Neurological disease or pathology of the neuromuscular system or any other disease that may affect the interpretation of study results; 13. 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; 14. Severe concomitant diseases, including cancer, which, in the opinion of the investigator, may affect the estimated parameters; 15. Uncontrolled hypertension (SBP ≥ 220 mm Hg. CL. and/or DBP ≥ 120 mm Hg. article in repeated measurements at the screening visit); 16. Uncontrolled angina, congestive heart failure or severe arrhythmia; 17. The presence of chronic infection (hepatitis B, C or AIDS) in the active form. 18. Severely impaired renal function or hepatic impairment (total bilirubin no more than 1.5 hvgn, the level of serum creatinine no more than 2.5 hugn and the levels of ALT, AST, GGT is not higher than 2.5 hvgn); 19. Diseases of the blood; 20. Mental illness, severe depression or suicide attempts in history; 21. The a history of drug addiction, alcoholism and abuse of drugs; 22. Contraindications to MRI: metal body, splinters, ferromagnetic implants (pacemakers, automatic dosing of drugs, implanted insulin pumps, artificial anus with a magnetic closure, artificial heart valves with metal elements), steel implants (clamps/clips on blood vessels, artificial joints, metal osteosynthesis devices), hearing AIDS; 23. Participation in any other clinical study within 30 days prior to screening or simultaneous participation in other clinical studies; 24. Pregnancy, breastfeeding or planning a pregnancy; 25. Women and men with preserved reproductive potential who refuse to use effective methods of contraception throughout the study; 26. Life expectancy less than 1 year; 27. Any disease or circumstances that, in the opinion of the investigator, may interfere with the subject participating in the study or in relation to which participation in the study may be dangerous for the subject; Premature withdrowal criteria: 1. The research subject may discontinue participation at any time without giving a reason; 2. The researcher ahead of time to exclude the patient from the study in the following cases; 3. The refusal of the subject from further participation in the study; 4. Failure to comply with the subject rules of participation in the study; 5. The reasons that emerged during the study and threatening the security of the subject, including those associated with taking study medication adverse events; 6. The entities with during the study pregnancy; 7. The application of the patient in the study period of any additional neuroprotective and nootropic drugs, drugs from the group of correctors of cerebral blood flow; 8. Other reasons arising in the course of the study and prevent the realization of the study according to the Protocol; 9. Repeated stroke in the course of the study; 10. Subjects who are lost to observation, also belong to prematurely withdrawn from the study.

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