The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

September 10, 2025 updated by: Tatchempharmpreparaty, JSC

Multicenter, Randomized, Double-blind, Placebo-controlled Comparative Study of the Efficacy and Safety of the Drug Dimephosphon®, Concentrate for Solution for Intravenous Administration, 1 g, in Acute Ischemic Stroke Patients

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke. The study includes a screening period (Visit 1, up to 48 hours) and a treatment period (Visits 2-4). Subjects will be randomized into 2 groups in a 1:1 ratio: Group A (investigational drug Dimephosphon®) and Group B (placebo). Key inclusion criteria: verified by CT/MRI current hemispheric ischemic stroke, NIHSS score ≥5 and ≤15 at screening. The study will assess clinical outcomes using standardized scales including NIHSS, mRS, MMSE, MoCA and EQ-5D.

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russia
      • Krasnodar, Russia, 350086
        • Not yet recruiting
        • State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of Health of the Krasnodar region
        • Contact:
      • Moscow, Russia, 117198
        • Recruiting
        • Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"
        • Contact:
      • Moscow, Russia, 117513
        • Recruiting
        • The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency
        • Contact:
      • Saint Petersburg, Russia, 197706
        • Recruiting
        • Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
        • Contact:
      • Sochi, Russia, 354057
        • Recruiting
        • State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region
        • Contact:
    • Leningradskaya Oblast'
      • Vsevolozhsk, Leningradskaya Oblast', Russia, 188643
        • Recruiting
        • State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
  2. Age 35-80.
  3. Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.
  4. Verified by CT/MRI current hemispheric ischemic stroke.
  5. NIHSS score ≥5 and ≤15 at screening.
  6. Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
  7. Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.

Exclusion Criteria:

  1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
  2. Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
  3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
  4. The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT/MRI data.
  5. Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form).
  6. Surgery on the carotid arteries less than 1 year before screening.
  7. History of stroke less than 1 year before screening.
  8. Myocardial infarction less than 6 months before screening.
  9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
  10. Pregnancy or lactation.
  11. Participation in another trial within 28 days prior to enrollment.
  12. Use of prohibited medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dimephosphon®

Days 1-3: Dimephosphon® 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).

Days 4-14: Dimephosphon® 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
Drug: Dimephosphon®
1 g/ml, concentrate for solution for intravenous infusion
Placebo Comparator: Placebo

Days 1-3: Placebo 2 g (2 vials) administered as intravenous infusion diluted in 200 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).

Days 4-14: Placebo 2 g (2 vials) administered as intravenous bolus diluted in 20 mL of 0.9% sodium chloride solution three times daily (morning, afternoon, and evening, with minimum 5-hour interval between administrations).
Drug: Placebo
Placebo IV solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 4 (Day 15)
Time Frame: Day 15
Day 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 3 (Day 8), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Day 8, Day 30, Day 90
Day 8, Day 30, Day 90
Change from Baseline (Visit 1, no more than 48 hours) in the National Institutes of Health Stroke Scale (NIHSS) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Visit 4 Day 15, Day 30, Day 90
Baseline, Day 8, Visit 4 Day 15, Day 30, Day 90
Percentage of subjects with changes from Baseline (Visit 1, no more than 48 hours) in NIHSS score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
Proportion of patients with a ≥4-point change in NIHSS score from Baseline (Visit 1, no more than 48 hours) at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), and Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
Proportion of patients with a ≥2-point change in NIHSS score from Baseline (Visit 1, no more than 48 hours) to Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
Change from Baseline (Visit 1, no more than 48 hours) in the Montreal Cognitive Assessment (MoCA) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
Change from Baseline (Visit 1, no more than 48 hours) in the Mini-Mental State Examination (MMSE) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
Change from Baseline (Visit 1, no more than 48 hours) in the EuroQol 5-Dimensions (EQ-5D) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90).
Time Frame: Baseline, Day 8, Day 15, Day 30, Day 90
Baseline, Day 8, Day 15, Day 30, Day 90
All-cause mortality from Visit 2 to Visit 6 (Hazard Ratio)
Time Frame: up to Day 90
up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatchempharmpreparaty, JSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 6, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMF-III-24 (Other Identifier: Tatchempharmpreparaty, JSC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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