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NCT04693715 · ClinicalTrials.gov registry record · Phase 2

Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy

A Phase 2 study, sponsored by Revalesio Corporation.

Completed
Registry status
Phase 2
Development phase
83
Enrollment target

NCT04693715: Completed Phase 2 study, sponsored by Revalesio Corporation.

NCT04693715 is a Phase 2 study that has completed, run by Revalesio Corporation. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04693715, a Phase 2 study, has completed, sponsored by Revalesio Corporation.

COMPLETED
Registry status
Phase 2
Development phase
83 participants
Enrollment target

Study Summary

A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h), 1.0 mL/kg/h RNS60 (up to a maximum of 130 mL/h), or 1.0 mL/kg/h (up to a maximum of 130 mL/h) placebo (normal saline) starting within 30 minutes of consent after confirmation of candidacy for endovascular thrombectomy.

Primary Outcome

An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in a congenital anomaly/birth defect. An SAE could also be an important medical event that may not have resulted in death, was life-threatening, or required hospitalization, but jeopardized the participant and required medical or su

Interventions

  • DRUG Placebo
  • DRUG RNS60

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2021-07-07
Est. Completion 2023-11-08
Phase Phase 2
Revalesio Corporation

6 total trials

What the finished NCT04693715 record still lists

NCT04693715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04693715 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04693715 about?

NCT04693715 is a clinical study titled "Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy". A Phase II, randomized, blinded, placebo-controlled, parallel group study with patients experiencing a large vessel occlusion acute ischemic stroke who are selected for endovascular revascularization. Participants will be given a 48 h infusion of either 0.5 mL/kg/h RNS60 (up to a maximum of 65 mL/h)...

What is the current status of trial NCT04693715?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2021-07-07. Estimated completion is 2023-11-08.

What interventions are being tested in trial NCT04693715?

The interventions under investigation include: Placebo (DRUG), RNS60 (DRUG).

Who is sponsoring clinical trial NCT04693715?

This trial is sponsored by Revalesio Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04693715's enrollment target sits among peer trials

83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04693715, the US trial registry maintained by the National Library of Medicine. NCT04693715 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.