Phase 4 Stroke Trial, Recruiting NCT05247125 Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Condition: Stroke
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Phase 4 Stroke Trial, Recruiting

NCT05247125
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had an ischemic stroke (a stroke caused by a blocked blood vessel) that started less than 1 day before being admitted to hospital
  • People whose stroke affected specific areas of the brain supplied by one of three main brain arteries (the anterior cerebral artery, middle cerebral artery, or posterior cerebral artery)
  • People aged between 18 and 80 years old
  • People with a moderate or severe stroke, based on a standard medical stroke severity score (NIHSS score of 5 or higher)
  • People who received a clot-dissolving medication or a procedure to remove a clot, with a satisfactory result — or people who did not require either of these treatments
  • People who are able and willing to provide informed consent to participate

Who may not be able to join:

  • People who have had significant bleeding into the brain tissue following their stroke
  • People who are medically unstable or have a life-threatening condition
  • People who have had another stroke in the past 6 months
  • People with a known progressive neurological disease (a condition that causes ongoing worsening of the nervous system)
  • People with a known psychiatric illness
  • People currently taking benzodiazepine medications (a type of sedative or anxiety medication)
  • People with a history of drug or alcohol misuse
  • People who are pregnant
  • People who are unable to participate in the study for any reason
  • People with severe difficulty understanding language due to their stroke (severe sensory aphasia)
  • People who were already taking melatonin before or at the time of admission to hospital
  • People who were already using light therapy before or at the time of admission to hospital
  • People who are blind
  • People with severe sleep apnea, where breathing stops and starts frequently during sleep (30 or more events per hour)
  • People with certain conditions or medications that make light therapy unsafe, including severe disease of the retina (back of the eye), epilepsy, porphyria (a rare metabolic condition), or use of medications that increase sensitivity to light
  • People with certain conditions that make melatonin unsafe, including severe asthma, severe autoimmune disorders, moderate-to-advanced chronic kidney disease, or certain blood cancers (leukosis) (confirm with trial site)
  • People with significant heart failure where the heart pumps poorly, based on standard medical measurements (ejection fraction of 45% or below, or a heart failure severity classification of Class III or IV)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Lyudmila Korostovtseva, Almazov National Medical Research Centre

Phone: +79217873548

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Registry
ClinicalTrials.gov
Start date
1 March 2022
Est. completion
30 January 2026

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Change in the value of National Institutes of Health Stroke Scale from baseline to 14 days after inclusion; Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14 days after treatment initiation; Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14 days after treatment initiation; Stroke-related disability assessed by the change in Barthel Index from baseline to 14 days after treatment initiation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov