Actively Recruiting
Multicenter, Randomized, Double-blind, Placebo-controlled Study of Dimephosphon4 for Intravenous Treatment of Acute Ischemic Stroke in Adults Aged 35 to 80
Led by Tatchempharmpreparaty, JSC · Updated on 2025-09-11
184
Participants Needed
6
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Dimephosphon4 in patients who have experienced an acute ischemic stroke. This multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 35 to 80 with verified hemispheric ischemic stroke confirmed by CT or MRI, and neurological scores between 5 and 15 on the NIH Stroke Scale. The trial aims to assess improvements in stroke outcomes using several clinical scales including the Modified Rankin Scale, NIH Stroke Scale, Mini-Mental State Examination, Montreal Cognitive Assessment, and EuroQol 5-Dimensions. Participants are randomly assigned to one of two groups: one receiving Dimephosphon4 and the other a placebo. In both groups, from days 1 to 3, the assigned treatment is given as an intravenous infusion three times daily with at least 5 hours between doses. From days 4 to 14, the treatment is administered as an intravenous bolus, also three times daily. The dosing involves 2 grams of the study drug or placebo diluted appropriately for each administration. During the study, participants undergo a screening period lasting up to 48 hours, followed by treatment visits on days 1 through 14, with follow-up assessments up to day 90. Researchers will monitor clinical outcomes and neurological function using established scales at multiple time points, including days 8, 15, 30, and 90. Safety and mortality will also be tracked. The total duration of participation spans from initial screening through the last follow-up visit at day 90.
CONDITIONS
Brief Title
The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from the patient or legally authorized representative prior to participation
- Age between 35 and 80 years
- Neurological symptoms consistent with acute ischemic stroke with onset-to-treatment time of 24 to 72 hours
- Current hemispheric ischemic stroke verified by CT or MRI
- NIH Stroke Scale score between 5 and 15 at screening
- Ability to comply with all study procedures and restrictions
- Willingness and ability to use highly effective contraception as required by the study protocol
You will not qualify if you...
- Hemorrhagic stroke or hemorrhagic transformation of ischemic stroke, traumatic brain injuries
- Vertebrobasilar stroke or acute insufficiency in vertebrobasilar arteries
- Candidates for or prior recipients of reperfusion therapy
- Anatomical abnormalities of cerebral vessels such as arteriovenous or cavernous malformations, aneurysms, or extracranial artery atresia
- Worsening neurological symptoms defined by an increase of 4 points in NIH Stroke Scale before randomization
- Carotid artery surgery within 1 year before screening
- History of stroke within 1 year before screening
- Myocardial infarction within 6 months before screening
- Chronic renal failure stage 2-3 with creatinine clearance less than 40 ml/min
- Pregnancy or breastfeeding
- Participation in another clinical trial within 28 days prior to enrollment
- Use of prohibited medications as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 48 hours
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 14 days
Participants receive either Dimephosphon® or placebo administered intravenously to treat acute ischemic stroke.
3 visits during treatment period (Days 1-3 and Days 4-14), including multiple daily infusions
Duration - Up to 75 days after treatment
Participants are monitored for safety and clinical outcomes after the treatment period.
3 visits on Days 30, 90, and additional assessments on Day 15
Trial Site Locations
Total: 6 locations
1
State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital
Vsevolozhsk, Leningradskaya Oblast', Russia, 188643
Actively Recruiting
2
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, 350086
Not Yet Recruiting
3
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"
Moscow, Russia, 117198
Actively Recruiting
4
The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency
Moscow, Russia, 117513
Actively Recruiting
5
Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg, Russia, 197706
Actively Recruiting
6
State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region
Sochi, Russia, 354057
Actively Recruiting
Research Team
A
Alfiya Fakhrieva
A
Alyona Tirskaya
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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