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

2 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The treatment being tested is called redasemtide (also known by its code name S-005151), which is administered as a lyophilized powder through an intravenous infusion. The study will compare the effects of redasemtide with a placebo in adult participants who have experienced an acute ischemic stroke and are not eligible for certain standard treatments like tissue plasminogen activator or thrombectomy.

The purpose of the study is to evaluate how effective and safe redasemtide is compared to a placebo. Participants in the study will receive either the redasemtide treatment or a placebo, and their progress will be monitored over a period of time. The study will involve regular check-ups and assessments to track the participants’ recovery and any changes in their condition. The main goal is to see if redasemtide can improve outcomes for people who have had an acute ischemic stroke.

Throughout the study, participants will be evaluated using various measures, including the mRS score, which assesses the degree of disability or dependence in daily activities, and the NIHSS score, which measures the severity of stroke symptoms. These assessments will help determine the effectiveness of the treatment. The study aims to provide valuable information on whether redasemtide can be a beneficial treatment option for those affected by acute ischemic stroke.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the study medication, redasemtide (S-005151), or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 treatment administration

The treatment involves receiving the assigned medication through an intravenous infusion. This means the medication is given directly into a vein using a needle. The infusion will be administered within 25 hours of the onset of the stroke symptoms.

3 monitoring and follow-up

Participants will be monitored regularly to assess their health and the effects of the treatment. This includes checking vital signs such as blood pressure, body temperature, respiratory rate, and pulse rate.

Participants will also undergo various assessments to evaluate their recovery progress. These assessments include the modified Rankin Scale (mRS) and the National Institutes of Health Stroke Scale (NIHSS), which measure the level of disability and neurological function, respectively.

Additional evaluations will be conducted at specific intervals, including at Day 30, Day 90, and Day 180, to track changes in health status and recovery.

4 completion of the study

The study is expected to conclude by December 31, 2024. Participants will have completed all necessary follow-up visits and assessments by this time.

Who Can Join the Study?

  • Must be a male or female adult who is 18 years or older.
  • Must be able to give informed consent, which means agreeing to participate after understanding the study details. If unable to consent, a legal representative can do so on their behalf.
  • Must have a diagnosis of ischemic stroke in a specific brain area, confirmed by a CT or MRI scan. These scans are special images of the brain.
  • Must be able to start the study treatment within 25 hours of stroke onset. If the exact time is unknown, the last time the person was known to be well is used.
  • Must not be eligible for certain stroke treatments like thrombolysis or endovascular therapy, which are procedures to restore blood flow.
  • Must have a NIHSS score between 8 and 22. This score measures the severity of the stroke.
  • Must be medically stable at the time of joining the study, meaning no major changes in health are expected soon.
  • Must weigh between 30 kg and 150 kg.
  • If female, must not be pregnant or breastfeeding. If able to have children, must use a reliable method of birth control and have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

  • Patients who have had a recent heart attack cannot participate. A heart attack is when blood flow to the heart is blocked.
  • Patients with severe liver disease are excluded. This means the liver is not working properly.
  • Patients with severe kidney disease cannot join. This means the kidneys are not functioning well.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with uncontrolled high blood pressure are excluded. This means blood pressure is too high and not managed by medication.
  • Patients with a history of bleeding disorders cannot participate. This means they have problems with blood clotting.
  • Patients who have had a major surgery in the last 3 months are not eligible. Major surgery is a significant operation that requires a hospital stay.
  • Patients with active cancer are excluded. This means cancer that is currently being treated or is spreading.
  • Patients with severe mental health conditions cannot join. This includes conditions that affect thinking, feeling, or behavior.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
University Of Debrecen Debrecen Hungary
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Hospital Vall d’Hebron Barcelona Spain
Zealand University Hospital, Department of Cardiology Roskilde Denmark
Hospital Universitario da A Coruna A Coruna Galicia Spain
Fakultni nemocnice Motol a Homolka Prague Czechia
Universitaetsklinikum Erlangen AöR Erlangen Germany
Assistance Publique Hopitaux De Marseille Marseille France
Alexandra Hospital Athens Greece
Helsinki University Central Hospital Helsinki Finland
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
General University Hospital Of Patras Patras Greece
Justus-Liebig-Universitaet Giessen Giessen Germany
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Katholieke Universiteit te Leuven Leuven Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Vrije Universiteit Brussel Jette Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University General Hospital Of Heraklion Heraklion Greece
Complexo Hospitalario Universitario De Vigo Vigo Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Hospital Universitario Virgen De La Victoria Malaga Spain
University General Hospital Attikon Athens Greece
Fondation A De Rothschild Paris France
Parc Tauli Hospital Universitari Sabadell Spain
Hospital Universitario Mutua Terrassa Terrassa Spain
Assistance Publique Hopitaux De Paris Paris France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Centre Hospitalier Universitaire De Nice Nice France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Gyor Hungary
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
University Of Pecs Pecs Hungary
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitari Joan XXIII De Tarragona Tarragona Spain

Other Sites

Site Name City Country Status
Hopital Purpan Toulouse France
Semmelweis University Budapest Hungary
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet Budapest Hungary
Ugluglqbwq Gnncwtk Hmghafsm On Iwbmsrvg Ioannina Greece
Bbxoueptbndssezevhbn Vxgwutovo Kdjurzety Kvuczb Ev Efnnacye Ofixelscrlml Miskolc Hungary
Acxhsv Nglrw Hiprpvlh Athens Greece
Kigulxxb Femfefzxc Hgbtkif Gwgl Frankfurt Germany
Ksfuecjfjx Fike Fczfyv Ksfate Kistarcsa Hungary
Ghbcosb Heuhjkid Oa Typmpljyvdqm Pobbicdlaxdc Thessaloniki Greece
Vedcaiyc Vmpggnghj Cwgejahd Fxhfaq Kzaxwy Veszprem Hungary
Bwscgknonwcyvslko Kklabs Ep Rggwvhqalgxluf Budapest Hungary
Mqtttof Cacitm Hjphgowuf Dutkywu Ffwsiu Budapest Hungary
Jzbtrkjwx Oxcl Kvwktc Vac Hungary
Kknudmdo Afjbaatnioo Laef Gnpr Altenburg Germany
Nzyggskjr Azan Okkvjbcpdxxhwgwgr aqdp Ostrava Czechia
Hbrwpsgh Ujmfxzcwirimr Dt Bhbuaff Badajoz Spain
Mlpzieogbpgqkmyjflqe Aoe Minden Germany
Anfespkw Zugvrvzufg Dglmdsi Omvgsiyd Ostend Belgium
Hpvohiys Ushmnuaceecnu Tfhpcnoxdwzjp Almeria Spain
Sxuue Drdlgf Gxoavwshzugpoyrz Kucbjb Kisvarda Hungary
Eafuftmnohyvwlf hyrdufchugaslqv Lappeenranta Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.08.2023
Czechia Czechia
Not recruiting
01.08.2023
Denmark Denmark
Not recruiting
01.08.2023
Finland Finland
Not recruiting
01.08.2023
France France
Not yet recruiting
01.08.2023
Germany Germany
Not recruiting
01.08.2023
Greece Greece
Not recruiting
01.08.2023
Hungary Hungary
Not recruiting
01.08.2023
Spain Spain
Not recruiting
01.08.2023

Trial locations

Investigated Drugs:

Redasemtide (S-005151) is a medication being studied for its potential to help people who have had an acute ischemic stroke. This type of stroke happens when a blood clot blocks a blood vessel in the brain, reducing blood flow and causing brain cells to die. Redasemtide is being tested to see if it can improve recovery by helping to repair and protect brain cells after a stroke. The trial is focused on patients who cannot receive other common stroke treatments like clot-busting drugs or surgical procedures to remove the clot. The goal is to see if redasemtide can help these patients recover better than if they received no active treatment at all.

Acute Ischemic Stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, vision problems, dizziness, and loss of balance or coordination. The progression of the disease can lead to significant neurological damage if blood flow is not quickly restored. The severity and specific symptoms depend on the location and extent of the blockage. Recovery and progression vary widely among individuals, influenced by the size and location of the stroke and the speed of medical intervention.

Trial ID:
2022-501890-38-00
Protocol code:
2138P2231
NCT ID:
NCT05953480
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study to evaluate the effectiveness of tenecteplase in patients with acute ischemic stroke who are more than 4.5 hours after their last known well time.

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Bulgaria Greece Hungary Norway Romania Spain
  • A Study of Tenecteplase for Acute Ischemic Stroke in Patients Taking Direct Oral Anticoagulants

    Recruiting

    3 1 1
    Investigated Diseases:
    Investigated Drugs:
    Germany