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Study · Randomized controlled trial · n = 490 · 2025

4 results

[Therapeutic equivalence of intravenous and intramuscular dosage forms of Cortexin in ischemic strokes].

Fedin AI, Khairova EN, Artyukov OP, Timchenko LV, Bazhenova OA, Gaiduk NV, Zykov MV

Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova1 Jan 2025

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke, day 90 mRS scores of 0-2 occurred in 93.64% with initial intravenous Cortexin versus 86.50% with intramuscular Cortexin.

    In plain wordsIn stroke patients, the share with a favorable disability score at day 90 was 93.64% with initial intravenous Cortexin and 86.50% with intramuscular Cortexin.

    Outcome
    Direction not reportedModified Rankin score 0-2 at day 90
    Study

    n = 490

    Comparator
    intramuscular Cortexin in both courses
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    10 mg twice daily · intravenous or intramuscular in the first course, intramuscular in the second course · two courses of 10 days eachAs given in this study (human).

    Measurements

    mRS 0-2
    93.64%
    initial intravenous Cortexin at day 90
    mRS 0-2
    86.5%
    intramuscular Cortexin at day 90

    Source sentences

    Summary
    The proportion of patients who reached 0-2 on the mRS scale on day 90 was 93.64% and 86.50% in the groups receiving Cortexin intravenously and intramuscularly, respectively.
    4 context sentences
    Summary · context
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted.
    Summary · context
    The study included 490 patients with acute IS, male (54.1%) and female (45.9%) aged from 30 to 80 years (average age 63.97+8.5 years), divided into 2 groups: 1 - main (Cortexin intravenous form, n=246), 2 - comparison (Cortexin intramuscular form, n=244).
    Summary · context
    In the first course: Group 1 - Cortexin 10 mg IV and placebo IM 2 times a day; Group 2 - Cortexin 10 mg IM and placebo IV 2 times a day.
    Summary · context
    After 10 days, patients in both groups received a second course of therapy with Cortexin 10 mg, IM, 2 times a day, 10 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke, NIHSS scores decreased by 3.93 with initial intravenous Cortexin and by 3.72 with intramuscular Cortexin.

    In plain wordsIn stroke patients, NIHSS scores decreased in both groups, with a numerically larger reduction after initial intravenous Cortexin than intramuscular Cortexin.

    Outcome
    Direction not reportedNIHSS score reduction
    Study

    n = 490

    Comparator
    intramuscular Cortexin in both courses
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    10 mg twice daily · intravenous or intramuscular in the first course, intramuscular in the second course · two courses of 10 days eachAs given in this study (human).

    Measurements

    NIHSS decrease
    3.93 points
    initial intravenous Cortexin
    NIHSS decrease
    3.72 points
    intramuscular Cortexin

    Source sentences

    Summary
    By the end of the follow-up period, the total score on the NIHSS scale decreased by 3.93 and 3.72, respectively, in both groups.
    4 context sentences
    Summary · context
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted.
    Summary · context
    The study included 490 patients with acute IS, male (54.1%) and female (45.9%) aged from 30 to 80 years (average age 63.97+8.5 years), divided into 2 groups: 1 - main (Cortexin intravenous form, n=246), 2 - comparison (Cortexin intramuscular form, n=244).
    Summary · context
    In the first course: Group 1 - Cortexin 10 mg IV and placebo IM 2 times a day; Group 2 - Cortexin 10 mg IM and placebo IV 2 times a day.
    Summary · context
    After 10 days, patients in both groups received a second course of therapy with Cortexin 10 mg, IM, 2 times a day, 10 days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In acute ischemic stroke, MMSE score changes were 4.11 with initial intravenous Cortexin and 3.88 with intramuscular Cortexin, without a significant difference.

    In plain wordsIn stroke patients, MMSE score changes did not differ significantly between initial intravenous Cortexin and intramuscular Cortexin.

    Outcome
    No significant changeMMSE score change
    Study

    n = 490

    Comparator
    intramuscular Cortexin in both courses
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    10 mg twice daily · intravenous or intramuscular in the first course, intramuscular in the second course · two courses of 10 days eachAs given in this study (human).

    Measurements

    MMSE change
    4.11 points
    initial intravenous Cortexin
    MMSE change
    3.88 points
    intramuscular Cortexin

    Source sentences

    Summary
    According to the MMSE scale, by the day of completion of the study, the overall dynamics of the average score in group 1 was 4.11, in the comparison group 3.88 (p=0.249).
    4 context sentences
    Summary · context
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted.
    Summary · context
    The study included 490 patients with acute IS, male (54.1%) and female (45.9%) aged from 30 to 80 years (average age 63.97+8.5 years), divided into 2 groups: 1 - main (Cortexin intravenous form, n=246), 2 - comparison (Cortexin intramuscular form, n=244).
    Summary · context
    In the first course: Group 1 - Cortexin 10 mg IV and placebo IM 2 times a day; Group 2 - Cortexin 10 mg IM and placebo IV 2 times a day.
    Summary · context
    After 10 days, patients in both groups received a second course of therapy with Cortexin 10 mg, IM, 2 times a day, 10 days.
  4. 04HumanRandomized controlled trialSafety outcome

    In acute ischemic stroke, adverse events totalled 74 (in 60 patients) with initial intravenous Cortexin and 51 (in 41 patients) with intramuscular Cortexin, without a significant between-group difference.

    In plain wordsIn stroke patients, adverse event counts did not differ significantly between initial intravenous Cortexin and intramuscular Cortexin.

    Outcome
    No significant changeAdverse event count
    Study

    n = 490

    Comparator
    intramuscular Cortexin in both courses
    Outcome group
    Adverse events · Whole body
    Studied dose
    10 mg twice daily · intravenous or intramuscular in the first course, intramuscular in the second course · two courses of 10 days eachAs given in this study (human).

    Measurements

    Adverse events
    74 events
    initial intravenous Cortexin
    Adverse events
    51 events
    intramuscular Cortexin
    Patients with adverse events
    60 patients
    initial intravenous Cortexin
    Patients with adverse events
    41 patients
    intramuscular Cortexin

    Source sentences

    Summary
    In the main group 1, 74 AES were registered in 60 patients, in the comparison group - 51 AES in 41 people, the number of cases did not differ between the groups (p>0.05).
    4 context sentences
    Summary · context
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted.
    Summary · context
    The study included 490 patients with acute IS, male (54.1%) and female (45.9%) aged from 30 to 80 years (average age 63.97+8.5 years), divided into 2 groups: 1 - main (Cortexin intravenous form, n=246), 2 - comparison (Cortexin intramuscular form, n=244).
    Summary · context
    In the first course: Group 1 - Cortexin 10 mg IV and placebo IM 2 times a day; Group 2 - Cortexin 10 mg IM and placebo IV 2 times a day.
    Summary · context
    After 10 days, patients in both groups received a second course of therapy with Cortexin 10 mg, IM, 2 times a day, 10 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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