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SOVATELTIDE

Clinical trials are investigating SOVATELTIDE in people with acute cerebral ischemic stroke. These studies aim to assess safety and efficacy, especially whether treatment improves recovery after stroke. The available trial data focus on adults with this condition in a Phase 3 study.

Table of Contents

Trial overview

The available clinical trial data show one interventional study of SOVATELTIDE in people with acute cerebral ischemic stroke.[1] The study is designed to assess both safety and efficacy, which means the researchers want to see whether the treatment can help recovery and how well it performs in the study setting.[1]

Who is being studied

The target condition is acute cerebral ischemic stroke, a sudden stroke caused by blocked blood flow to the brain.[1] The trial data do not provide more detailed eligibility rules, so the main population described is patients with this condition.[1]

Study design and treatment groups

This study is a Phase 3 trial, which is a later-stage study that usually tests how well a treatment works in a larger group of people.[1] Participants are assigned to receive either SOVATELTIDE or a matching placebo, so the researchers can compare outcomes between the two groups.[1]

The trial lists SOVATELTIDE as an intravenous treatment at 0.9 µg/Kg, and the comparison arm uses a matching placebo.[1] An intravenous treatment is given through a vein.[1]

What the trial measures

The main endpoint, also called the primary efficacy endpoint, is the proportion of patients with a good functional outcome on day 90 after randomization.[1] A good functional outcome is defined as a modified Rankin Scale score of 0 to 2.[1]

The modified Rankin Scale (mRS) is a stroke recovery scale used to measure disability and independence in daily life.[1] In this study, lower scores mean better recovery, and a score of 0 to 2 is considered a favorable result.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 452 participants, which gives the study enough size to compare recovery results across the groups.[1]

Only one clinical trial is provided in the source data, so the article focuses on this single Phase 3 study of SOVATELTIDE in acute cerebral ischemic stroke.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05691244 Phase 3 Acute cerebral ischemic stroke Authorised 452

FAQ

  • What is being studied in the SOVATELTIDE trial? The trial is studying whether SOVATELTIDE helps people recover better after acute cerebral ischemic stroke. It compares SOVATELTIDE with a matching placebo.
  • Who can take part in the trial? The trial is for patients with acute cerebral ischemic stroke. The study data do not list more detailed eligibility rules.
  • What phase is the SOVATELTIDE study? This is a Phase 3 trial. Phase 3 studies usually test how well a treatment works in a larger group of people and continue to look at safety.
  • What outcome is the trial measuring? The main outcome is the number of patients with a good functional outcome at day 90. This is measured using the modified Rankin Scale, where a score of 0 to 2 means better recovery.
  • How many people are planned for the study? The trial plans to enroll 452 participants. This larger number helps researchers compare results more reliably.

Ongoing Clinical Trials on SOVATELTIDE

  • Study on the Safety and Effectiveness of Sovateltide for Patients with Acute Ischemic Stroke

    Recruiting

    1 1
    Investigated drugs:
    Germany Spain

Glossary

  • Acute cerebral ischemic stroke: A sudden stroke caused by blocked blood flow to part of the brain. This can damage brain tissue and affect movement, speech, or thinking.
  • Efficacy: How well a treatment works in a study.
  • Safety: How well a treatment is tolerated and whether it causes problems that researchers are watching for.
  • Phase 3: A later stage of clinical research that usually includes more participants and looks closely at how well a treatment works.
  • Interventional study: A study where researchers give a treatment and compare outcomes between groups.
  • Placebo: A treatment that looks like the study drug but does not contain the active study treatment.
  • Randomization: A method of assigning participants to study groups by chance.
  • Modified Rankin Scale (mRS): A scale used after stroke to measure disability and recovery. Lower scores mean less disability.
  • Functional outcome: How well a person can do everyday activities after illness or treatment.
  • Enrollment: The number of people planned to join a study.

References