Phase 4 Stroke Trial, Recruiting NCT05955326 Sponsor: Pharmazz, Inc. Condition: Stroke
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Phase 4 Stroke Trial, Recruiting

NCT05955326
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:

  • Adults between 18 and 78 years old (who have not yet turned 79)
  • People, or their legal representative, who are willing to give consent before any study procedures begin
  • People who have had an ischemic stroke (caused by a blockage, not bleeding) that has been confirmed by a CT scan or MRI before joining the trial
  • People who arrived for treatment within 24 hours of stroke symptoms starting, who had little to no disability before the stroke, and whose stroke caused moderate-to-severe symptoms on standard medical rating scales — but who are not deeply unresponsive (confirm with trial site for exact score details)
  • People whose first dose of the study drug (Sovateltide) can be given within 24 hours of when symptoms began — or, for strokes that happened during sleep, within 24 hours of when the person was last known to be well
  • People who are expected to be available to complete the full course of the study drug and attend all follow-up visits
  • People who previously had a stroke but fully recovered before having a new stroke may also be considered

Who may not be able to join:

  • People who are receiving, or are being considered for, a procedure to physically open or treat a blocked blood vessel in the brain (such as endovascular therapy or surgery)
  • People who are in a deeply unresponsive state and require strong or repeated stimulation to respond (confirm with trial site for exact scoring details)
  • People whose brain scans show any type of bleeding in or around the brain
  • People who are pregnant
  • People who have a pre-existing neurological or psychiatric condition that could affect the results
  • People who are already taking part in another treatment-based clinical trial
  • People who have another serious or life-threatening medical condition that could interfere with completing the study, affect how results are measured, or for whom the study drug may be harmful

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: Manish Lavhale, Ph.D., Pharmazz India

Phone: +91(120)256-9779

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
Pharmazz, Inc.
Registry
ClinicalTrials.gov
Start date
8 January 2024
Est. completion
1 February 2026

Where this trial is recruiting

🇮🇳 India

Primary endpoints

The proportion of patients with adverse events (AEs) and serious adverse events (SAEs)

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