Health TrialsbyHealthPanel

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

ConditionsStrokeAcute StrokeIschemic StrokeCerebrovascular DisordersPhysiological Effects of Drugs
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-80
SponsorTatchempharmpreparaty, JSC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dimephosphon®

    Drug

    1 g/ml, concentrate for solution for intravenous infusion

  • Placebo

    Drug

    Placebo IV solution

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: Dimephosphon®Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of subjects having Modified Rankin Scale (mRS) scores 0-2 at Visit 4 (Day 15)

Time frame
Day 15

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tatchempharmpreparaty, JSC

Lead sponsor

Source ClinicalTrials.gov
Apply now