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

Official title

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

Overview

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

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled trial. The purpose of the study is to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke. The study includes a screening period (Visit 1, up to 48 hours) and a treatment period (Visits 2-4). Subjects will be randomized into 2 groups in a 1:1 ratio: Group A (investigational drug Dimephosphon®) and Group B (placebo). Key inclusion criteria: verified by CT/MRI current hemispheric ischemic stroke, NIHSS score ≥5 and ≤15 at screening. The study will assess clinical outcomes using standardized scales including NIHSS, mRS, MMSE, MoCA and EQ-5D.

Interventions

• Drug Dimephosphon®
  1 g/ml, concentrate for solution for intravenous infusion
• Drug Placebo
  Placebo IV solution

Primary outcome measures

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

Secondary outcome measures (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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: Baseline, Day 8, Day 15, Day 30, Day 90]
• Change from Baseline (Visit 1, no more than 48 hours) in the Montreal Cognitive Assessment (MoCA) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90). [Time frame: Baseline, Day 8, Day 15, Day 30, Day 90]
• Change from Baseline (Visit 1, no more than 48 hours) in the Mini-Mental State Examination (MMSE) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90). [Time frame: Baseline, Day 8, Day 15, Day 30, Day 90]
• Change from Baseline (Visit 1, no more than 48 hours) in the EuroQol 5-Dimensions (EQ-5D) score at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 30), Visit 6 (Day 90). [Time frame: Baseline, Day 8, Day 15, Day 30, Day 90]
• All-cause mortality from Visit 2 to Visit 6 (Hazard Ratio) [Time frame: up to Day 90]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Russia · 6 centers

• State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict — Vsevolozhsk
• State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No — Krasnodar
• Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship — Moscow
• The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical a — Moscow
• Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kuror — Saint Petersburg
• State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of H — Sochi

Identifiers

NCT: NCT07167550 · DMF-III-24 · DMF-III-24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗