#1 Clinical Trials Search in Europe

Redasemtide

Redasemtide, also known as S-005151, is an investigational drug currently being studied in clinical trials for the treatment of acute ischemic stroke. This article explores the ongoing phase 2b clinical trial that aims to evaluate the efficacy and safety of Redasemtide in adult patients who are not eligible for standard treatments like tissue plasminogen activator (tPA) or thrombectomy. The trial focuses on patients with supratentorial ischemic stroke and compares Redasemtide to a placebo in a randomized, double-blind study.

Table of Contents

What is Redasemtide?

Redasemtide, also known as S-005151, is a new medication being studied for the treatment of acute ischemic stroke. An acute ischemic stroke occurs when blood flow to part of the brain is blocked, usually by a blood clot, leading to damage of brain tissue[1]. Redasemtide is currently undergoing clinical trials to assess its effectiveness and safety in treating this serious condition.

How Redasemtide Works

While the exact mechanism of action is not fully described in the provided information, Redasemtide is being investigated as a potential treatment for patients who are not eligible for standard stroke treatments. These standard treatments typically include:

  • Tissue plasminogen activator (tPA): A medication that helps dissolve blood clots
  • Thrombectomy: A surgical procedure to remove blood clots from blood vessels in the brain

Redasemtide is administered as an intravenous (IV) infusion, which means it’s given directly into the bloodstream through a vein. This method allows the medication to reach the affected areas of the brain quickly[1].

Clinical Trial Details

A Phase 2b clinical trial is currently underway to further investigate the efficacy and safety of Redasemtide. Here are some key details about the study:

  • It’s a multinational, randomized, double-blind study, which means participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving which treatment.
  • The study compares two different doses of Redasemtide (0.75 mg/kg and 1.5 mg/kg) to a placebo (a substance with no active medication).
  • The medication is given once daily for 5 consecutive days during hospitalization.
  • The study follows participants for 180 days after treatment, with check-ups at 30, 90, and 180 days[1].

Eligibility Criteria

Not everyone with an acute ischemic stroke is eligible for this study. Some key eligibility criteria include:

  • Adults aged 18 years or older
  • Diagnosed with a specific type of ischemic stroke (supratentorial)
  • Able to start treatment within 25 hours of stroke onset
  • Not eligible for standard treatments like tPA or thrombectomy
  • Have a certain level of stroke severity, as measured by a standardized scale (NIHSS score of 8 to 22)
  • Medically stable except for the stroke and its complications[1]

Potential Benefits

The main goal of this study is to see if Redasemtide can improve outcomes for stroke patients. Researchers are looking at several measures to determine if the medication is effective, including:

  • Improvement in physical function and disability (measured by scales like the modified Rankin Scale or mRS)
  • Improvement in daily living activities (measured by the Barthel Index or BI)
  • Reduction in stroke severity (measured by the National Institutes of Health Stroke Scale or NIHSS)
  • Improvement in quality of life[1]

Safety and Side Effects

An earlier Phase 2 study of Redasemtide showed promising results:

  • The medication was well-tolerated by patients.
  • The number of side effects (called treatment-emergent adverse events or TEAEs) was similar between the Redasemtide group and the placebo group.
  • There were no notable differences in the types of side effects between the groups[1].

However, it’s important to note that this is still an investigational medication, and more research is needed to fully understand its safety profile and potential side effects.

In conclusion, Redasemtide represents a potential new treatment option for patients with acute ischemic stroke who are not eligible for current standard treatments. While the results so far are encouraging, it’s important to remember that this medication is still in the testing phase. Patients interested in learning more about Redasemtide or the ongoing clinical trial should consult with their healthcare providers.

Aspect Details
Drug Name Redasemtide (S-005151)
Study Type Phase 2b, multinational, randomized, double-blind
Condition Acute Ischemic Stroke
Participant Criteria Adults ≥18 years, supratentorial ischemic stroke, NIHSS score 8-22, not eligible for tPA or thrombectomy
Treatment IV infusion once daily for 5 consecutive days (0.75 mg/kg or 1.5 mg/kg)
Primary Endpoint Modified Rankin Scale (mRS) score at Day 90
Secondary Endpoints Functional independence, neurological improvement, quality of life measures
Study Duration 6 months (5-day treatment + 180-day follow-up)
Safety Monitoring Adverse events, lab tests, vital signs, ECGs, and suicide risk assessment

FAQ

  • What is Redasemtide and what is it being studied for? Redasemtide (S-005151) is an investigational drug being studied for the treatment of acute ischemic stroke. It is specifically being tested in patients who are not eligible for standard treatments like tissue plasminogen activator (tPA) or thrombectomy.
  • How is Redasemtide administered in the clinical trial? In the clinical trial, Redasemtide is administered as an intravenous (IV) infusion once daily over 90 minutes for 5 consecutive days during hospitalization. The study is testing two different doses: 0.75 mg/kg and 1.5 mg/kg.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults aged 18 years or older with a diagnosis of supratentorial ischemic stroke, confirmed by CT or MRI. They must have a baseline NIHSS score of 8 to 22 and be able to start treatment within 25 hours of stroke onset. Importantly, participants must not be eligible for standard treatments like tPA or thrombectomy.
  • What are the main goals of this clinical trial? The main objectives of this trial are to compare the efficacy of Redasemtide with that of a placebo and to evaluate its safety and tolerability in patients with acute ischemic stroke. The primary endpoint is the modified Rankin Scale (mRS) score at Day 90, which measures the degree of disability or dependence in daily activities.
  • How long does the clinical trial last and what does it involve? The clinical trial lasts for 6 months, with a 5-day treatment period followed by a 180-day follow-up period. During the follow-up, participants will have three visits: at day 30, day 90, and day 180. The study will assess various outcomes, including functional independence, neurological improvement, and quality of life measures.

Ongoing Clinical Trials on Redasemtide

  • Study on Redasemtide for Adults with Acute Ischemic Stroke Not Eligible for Standard Treatments

    Not yet recruiting

    2 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +3

Glossary

  • Acute Ischemic Stroke: A sudden interruption of blood flow to part of the brain, causing a lack of oxygen and potentially leading to brain damage.
  • Redasemtide (S-005151): An investigational drug being studied for the treatment of acute ischemic stroke, administered through intravenous infusion.
  • Tissue Plasminogen Activator (tPA): A standard treatment for ischemic stroke that helps break down blood clots.
  • Thrombectomy: A surgical procedure to remove a blood clot from a blood vessel in the brain.
  • Modified Rankin Scale (mRS): A scale used to measure the degree of disability or dependence in daily activities of people who have suffered a stroke.
  • NIHSS (National Institutes of Health Stroke Scale): A tool used to objectively quantify the impairment caused by a stroke.
  • Supratentorial: Referring to the upper part of the brain, above the tentorium cerebelli.
  • CT (Computed Tomography): An imaging technique that uses X-rays to create detailed pictures of structures inside the body.
  • MRI (Magnetic Resonance Imaging): A medical imaging technique that uses strong magnetic fields and radio waves to produce detailed images of the body.
  • Intravenous (IV) Infusion: A method of delivering medications directly into a vein over a period of time.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Randomized, Double-blind Study: A study design where participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving which treatment.
  • Barthel Index (BI): A scale used to measure performance in activities of daily living.
  • SF-36: A 36-item questionnaire that measures quality of life across eight domains of health.
  • SAQoL-39g: Stroke and Aphasia Quality of Life Scale-39 generic version, used to assess quality of life in stroke survivors.

References

  1. http://clinicaltrials.eu/trial/study-on-redasemtide-for-adults-with-acute-ischemic-stroke-not-eligible-for-standard-treatments/