Dimephosphon® for recovery after acute ischemic stroke.

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

This trial will test whether Dimephosphon® given 24–72 hours after stroke onset helps adults with moderate acute ischemic stroke recover better than a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Tatchempharmpreparaty, JSC (Industry-sponsored)
• Locations: 6 sites (Vsevolozhsk, Leningradskaya Oblast' and 5 other locations)
• Trial ID: NCT07167550 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that randomizes eligible patients 1:1 to receive Dimephosphon® or placebo. Adults aged 35–80 with CT/MRI-confirmed hemispheric ischemic stroke and NIHSS scores of 5–15 who can start treatment 24–72 hours after symptom onset are enrolled. The protocol includes a screening visit (up to 48 hours) and a series of treatment visits, with outcomes measured using NIHSS, modified Rankin Scale (mRS), MMSE, MoCA, and EQ-5D. Both efficacy and safety endpoints will compare clinical and cognitive outcomes between the Dimephosphon® and placebo groups.

Who should consider this trial

Good fit: Adults aged 35–80 with CT/MRI-confirmed hemispheric ischemic stroke, NIHSS 5–15 at screening, able to begin treatment 24–72 hours after onset and able to provide consent or have a legal representative do so are the intended participants.

Not a fit: Patients with hemorrhagic stroke or hemorrhagic transformation, vertebrobasilar strokes, traumatic brain injury, or those outside the NIHSS or 24–72 hour treatment window are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, Dimephosphon® could improve neurological recovery and reduce disability after moderate acute ischemic stroke.

How similar studies have performed: Neuroprotective agents historically have had limited success in large trials, so this Phase 3 test of Dimephosphon® seeks to confirm earlier signals in a challenging therapeutic area.

Eligibility criteria

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.

Where this trial is running

Vsevolozhsk, Leningradskaya Oblast' and 5 other locations

• State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital — Vsevolozhsk, Leningradskaya Oblast', 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, Russia (Not_yet_recruiting)
• Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba" — Moscow, Russia (Recruiting)
• The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency — Moscow, Russia (Recruiting)
• Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District" — Saint Petersburg, Russia (Recruiting)
• State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region — Sochi, Russia (Recruiting)

Study contacts

• Study coordinator: Alfiya Fakhrieva

Conditions Stroke; Acute Stroke; Ischemic Stroke; Cerebrovascular Disorders; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Neuroprotection