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

NCT07167550 | Recruiting Phase 3 DMC

• 1 other identifier: DMF-III-24
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Stroke; Acute Stroke; Ischemic Stroke; Cerebrovascular Disorders; Physiological Effects of Drugs

Keywords

Neuroprotective Agents; Protective Agents; Neuroprotection; Anti-acidemic agents; Dimephosphon; Dimethyloxobutylphosphonyldimethylate; Acute Stroke; Ischemic Stroke; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 4 (Day 15)

  Day 15

Secondary Outcomes (9)

• Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 3 (Day 8), Visit 5 (Day 30), Visit 6 (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).

  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).

  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).

  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).

  Baseline, Day 8, Day 15, Day 30, Day 90

Study Arms (2)

Dimephosphon®

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Interventions

Dimephosphon® DRUG

1 g/ml, concentrate for solution for intravenous infusion

Dimephosphon®

Placebo DRUG

Placebo IV solution

Placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
• Age 35-80.
• 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.
• Verified by CT/MRI current hemispheric ischemic stroke.
• NIHSS score ≥5 and ≤15 at screening.
• Ability to comply with all protocol-specified procedures, prohibitions, and restrictions.
• Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol.

You may not qualify if:

• Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
• Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
• A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
• 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.
• 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).
• Surgery on the carotid arteries less than 1 year before screening.
• History of stroke less than 1 year before screening.
• Myocardial infarction less than 6 months before screening.
• Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min).
• Pregnancy or lactation.
• Participation in another trial within 28 days prior to enrollment.
• Use of prohibited medications.

Sponsors & Collaborators

• Tatchempharmpreparaty, JSC: lead

Study Sites (6)

State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital

Vsevolozhsk, Leningradskaya Oblast', 188643, Russia

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

Krasnodar, 350086, Russia

NOT YET RECRUITING

Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"

Moscow, 117198, Russia

RECRUITING

The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency

Moscow, 117513, Russia

RECRUITING

Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"

Saint Petersburg, 197706, Russia

RECRUITING

State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region

Sochi, 354057, Russia

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebrovascular Disorders

Interventions

dimephosphon

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Alfiya Fakhrieva

CONTACT

+78435269764; iksanova@tatpharm.ru

Alyona Tirskaya

CONTACT

+7812309847; atirskaya@x7research.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: September 6, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

RU (6)