Dimephosphon® for recovery after acute ischemic stroke.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital
  Vsevolozhsk, Leningradskaya Oblast', Russia 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
• 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

Study contacts

• Study coordinator: Alfiya Fakhrieva
• Email: iksanova@tatpharm.ru
• Phone: +78435269764

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for Acute Ischemic Stroke using DM199

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.