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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Russian Federation
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
NOT_YET_RECRUITING
Krasnodar
Federal State Autonomous Educational Institution of Higher Education Peoples' Friendship University of Russia named after Patrice Lumumba
RECRUITING
Moscow
The FSBI Federal Center of Brain Research and Neurotechnologies of the Federal Medical and Biological Agency
RECRUITING
Moscow
Saint Petersburg State Budgetary Healthcare Institution City Hospital No. 40 of the Kurortny District
RECRUITING
Saint Petersburg
State Budgetary Healthcare Institution City Hospital No. 4 of Sochi of the Ministry of Healthcare of the Krasnodar Region
RECRUITING
Sochi
State Budgetary Healthcare Institution of the Leningrad Region Vsevolozhsk Interdistrict Clinical Hospital
RECRUITING
Vsevolozhsk
Contact Information
Primary
Alfiya Fakhrieva
iksanova@tatpharm.ru
+78435269764
Backup
Alyona Tirskaya
atirskaya@x7research.ru
+7812309847
Time Frame
Start Date:2025-09-06
Estimated Completion Date:2026-04-30
Participants
Target number of participants:184
Treatments
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).
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).