The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
NCT ID: NCT07167550
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
184 participants
INTERVENTIONAL
2025-09-06
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
NCT03198715
Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke
NCT03552354
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
NCT00856661
Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke
NCT03290560
THR-18's Pharmacokinetics and Pharmacodynamics in Subjects With Acute Ischemic Stroke Treated With tPA
NCT01957774
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Dimephosphon®
1 g/ml, concentrate for solution for intravenous infusion
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).
Placebo
Placebo IV solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dimephosphon®
1 g/ml, concentrate for solution for intravenous infusion
Placebo
Placebo IV solution
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
35 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tatchempharmpreparaty, JSC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital
Vsevolozhsk, Leningradskaya Oblast', Russia
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, , Russia
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"
Moscow, , Russia
The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency
Moscow, , Russia
Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg, , Russia
State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region
Sochi, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DMF-III-24
Identifier Type: OTHER
Identifier Source: secondary_id
DMF-III-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.