Study on JX10 for Improving Outcomes in Patients with Acute Ischemic Stroke

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called JX10 on patients who have experienced an acute ischemic stroke. An acute ischemic stroke occurs when a blood clot blocks a blood vessel in the brain, leading to a sudden loss of blood flow and potentially causing brain damage. The study aims to determine if JX10 can improve recovery and reduce symptoms in patients who have had this type of stroke.

Participants in the study will receive either the JX10 treatment or a placebo, which is a substance with no active medication. The treatment is given as an infusion, meaning it is administered directly into the bloodstream through a vein. The study will compare the outcomes of those receiving JX10 with those receiving the placebo to see if there is a significant difference in recovery and symptom improvement.

The study will monitor participants over a period of time to assess their recovery and any potential side effects, such as the risk of bleeding in the brain, known as intracranial hemorrhage. The main goal is to see if JX10 can help patients have fewer or milder symptoms 90 days after their stroke. Participants will be closely observed to ensure their safety and to gather information on how well the treatment works.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must meet certain criteria, such as being between 18 and 90 years old and having experienced an acute ischemic stroke. Additional medical assessments will confirm your eligibility.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status. This includes a review of your medical history and a physical examination.

Imaging tests, such as a CT or MRI scan, will be performed to assess the condition of your brain and blood vessels.

3 treatment administration

You will receive either the study medication, JX10, or a placebo. A placebo is a substance with no active medication, used for comparison.

JX10 is administered as a sterile powder mixed into a solution and given through an intravenous infusion. This means it is delivered directly into your bloodstream through a vein.

The treatment will be administered within 4.5 to 24 hours after the onset of stroke symptoms, depending on your specific condition and imaging results.

4 monitoring and follow-up

After receiving the treatment, you will be closely monitored for any changes in your condition. This includes regular check-ups and assessments of your neurological function.

You will be observed for any side effects, particularly the risk of bleeding in the brain, which is a potential concern with this treatment.

5 final evaluation

A final evaluation will be conducted 90 days after the treatment to assess your recovery and any lasting effects of the treatment.

The primary goal is to determine if you have minimal or no symptoms and to evaluate the safety of the treatment.

Who Can Join the Study?

Age must be between 18 and 90 years old. If you are older than 85, you must have been fully independent before the stroke.
You or your legal representative must provide written consent to participate.
You must have an acute ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels of the brain.
The stroke must be confirmed by specific imaging tests like CT Angiography (CTA) or Magnetic Resonance Angiography (MRA), which are scans that show blood flow in the brain.
There must be evidence of salvageable brain tissue, meaning parts of the brain that can still be saved, shown by specific imaging tests.
You must be able to start the study treatment within 4.5 to 6 hours after the stroke if no imaging is done, or within 4.5 to 24 hours if imaging shows salvageable tissue.
Your initial stroke severity score, called the NIH Stroke Scale (NIHSS), must be 5 or higher. This scale measures the effects of a stroke.
You must have been functionally independent before the stroke, meaning you could perform daily activities without help.
If you are a woman who can have children, you must have a negative pregnancy test and use effective birth control during the study and for 30 days after the last dose of the study treatment.
If you are a man, you must use effective birth control during the study and for 90 days after the last dose of the study treatment. You should not donate sperm during this time.

Who Cannot Join the Study?

Patients who have had a recent head injury or brain surgery.
Patients with a history of bleeding disorders. This means any condition that makes it hard for the blood to clot.
Patients who are currently taking blood thinners. These are medications that prevent blood clots.
Patients with severe liver or kidney disease. This refers to serious problems with the liver or kidneys.
Patients who have had a major surgery in the last 30 days.
Patients with uncontrolled high blood pressure. This means blood pressure that is not managed well with medication.
Patients who are pregnant or breastfeeding.
Patients with a known allergy to the study medication or its ingredients.
Patients who have participated in another clinical trial in the last 30 days.
Patients with a serious infection. This means an infection that requires treatment with antibiotics or other medications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Unidade Local De Saude De Almada-Seixal E.P.E.	Almada	Portugal
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Barmherzige Brueder Trier gGmbH	Trier	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Del Mar	Barcelona	Spain
San Camillo Forlanini Hospital	Rome	Italy
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Unidade Local De Saude De Loures-Odivelas EPE	Loures	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Daugavpils regionala slimnica SIA	Daugavpils	Latvia
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Hospital General Universitario De Albacete	Albacete	Spain
Henry Dunant Hospital Center	Athens	Greece
Multiprofile Hospital For Active Treatment Blagoevgrad AD	Blagoevgrad	Bulgaria
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Fondation A De Rothschild	Paris	France
Hospital Universitario Ramon Y Cajal	Madrid	Spain
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Hospital Universitario Virgen Macarena	Sevilla	Spain
Respublikine Vilniaus universitetine ligonine VÅ¡Ä®	Vilnius	Lithuania
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Universita’ Degli Studi Di Verona	Verona	Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Semmelweis University	Budapest	Hungary
Hospital Universitario De Cruces	Barakaldo	Spain
Alessandro Manzoni Hospital	Lecco	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Jessa Ziekenhuis	Hasselt	Belgium
General University Hospital Of Patras	Patras	Greece
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Uvsuqaa Ltkab dh Scnya dz Aqdefji Ezbqjx	Faro	Portugal
Kfqyihik Amistfjgazp Lxvi Ghst	Altenburg	Germany
Wkbumzhfcbs Wptyzgqhnczsmaofvtja Cltleik Oudvndumb I Tbjdtoiuueech Ic Mazgmbhbjht W Lfsjs	Lodz	Poland
Rcam Exth Cfjjfuvw Ubzonnxbkb Hkuksgjg	Riga	Latvia
Hvqddhft Ugmhnlmdwuevx Rzfhcgua Dd Mtdzti	Malaga	Spain
Hjtgvjvq Uhsbeamgpm Cwdjsaw Hejvxiyn	Helsinki	Finland
Cvnrlh Hdxyvuqalbg Rflpgdeq Uhwnuiegrnyrq Dq Tcydk	Tours	France
Cdhg Dd Nxxxy	Vandoeuvre Les Nancy	France
Gjtmrq Ujsjvmcwfu Fvhyjcoex	Frankfurt	Germany
Feikiwewp Peej Lr Ihecbnsvxcdqj Bvgguaxew Dmv Htpqdebe Uibnkxcuepura Lr Pwa	Madrid	Spain
Hkwlolsw Vmce davkfjrg	Barcelona	Spain
Hrbeqawe Uonqnkgpwgiff du A Cjwqqb	A Coruna Galicia	Spain
Unbxtnmqyp Gjgokyp Hinbbftq Aweqyxo	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.07.2025
Bulgaria	Recruiting	01.07.2025
Finland	Not yet recruiting	01.07.2025
France	Recruiting	01.07.2025
Germany	Recruiting	01.07.2025
Greece	Recruiting	01.07.2025
Hungary	Recruiting	01.07.2025
Italy	Recruiting	01.07.2025
Latvia	Recruiting	01.07.2025
Lithuania	Recruiting	01.07.2025
Poland	Recruiting	01.07.2025
Portugal	Recruiting	01.07.2025
Spain	Recruiting	01.07.2025

Trial locations

JX10 is a medication being tested to see if it can help people who have had a type of stroke called an acute ischemic stroke. This kind of stroke happens when a blood clot blocks blood flow to the brain. The study is looking at whether JX10 can improve how well people recover and function after having this kind of stroke. Researchers are also checking if JX10 increases the risk of bleeding in the brain, which is a possible side effect. The goal is to find out if JX10 can help people recover better from strokes without causing serious side effects.

Investigated diseases:

Ischaemic stroke

Acute ischemic stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a sudden reduction in blood flow. This interruption in blood supply results in the deprivation of oxygen and nutrients to brain tissue, leading to the death of brain cells. The progression of the disease can lead to sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. Other symptoms may include vision problems, dizziness, loss of balance, or severe headache. The severity and specific symptoms depend on the location and extent of the brain affected. Immediate medical attention is crucial to minimize brain damage and potential complications.

Trial ID:

2024-519521-37-01

Protocol code:

JX10002

Trial Phase:

Therapeutic use (Phase IV)

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Study on JX10 for Improving Outcomes in Patients with Acute Ischemic Stroke

What is this study about?

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