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Tests treatment safety and results for Acute Ischemic Stroke
Official title Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
ClinicalTrials.gov ID: NCT05691244
What this study is testing
What is Drug: Normal Saline?
Drug: Normal Saline is an investigational medicine, being studied as a potential treatment for acute ischemic stroke.
Also referred to as Vehicle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:
- Adult males or females aged 18 - 80 years of age.
- Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
- A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic...
- Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of...
You likely can't join if
- A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:
- Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not...
- Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful...
- Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute...
- Known pregnancy and lactating women.
- Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would...
See the full eligibility criteria
- A patient will be eligible for inclusion in the study if he/she fulfills the following criteria:
- Adult males or females aged 18 - 80 years of age.
- Consent obtained per national laws and regulations, and in accordance with the applicable ethics committee requirements prior to study procedures.
- A stroke is ischemic in origin that is diagnosed clinically and/or radiologically confirmed by Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) prior to enrolment. No hemorrhage as proved by...
- Cerebral ischemic stroke patients presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and \<20, NIHSS Level of Consciousness (1A) score \<2 at the time of screening. This includes cerebral...
- The patient is \<24 hours from the time of stroke onset when the first dose of sovateltide is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient...
- Reasonable expectation of availability to receive the full sovateltide/placebo course of therapy and to be available for subsequent follow-up visits.
- A patient will not be eligible for inclusion in this study if they meet any of the following exclusion criteria:
- Patients receiving endovascular therapy or is a candidate for any surgical intervention for the treatment of stroke, which may include but not limited to endovascular techniques.
- Patients classified as comatose are defined as a patient who requires repeated stimulation to attend or is obtunded and requires strong or painful stimulation to make movements (NIHSS Level of Consciousness (1A) score...
- Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
- Known pregnancy and lactating women.
- Known medical history of neurological (other than current acute ischemic stroke) or psychiatric condition that, in the investigator's opinion, would confound the neurological and functional evaluations, lead to further...
- Concurrent participation in any other therapeutic clinical trial.
- Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol impair the assessment of outcome, or in which sovateltide therapy would be contraindicated or...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Carmichael, California, United States
- Oxnard, California, United States
- Sarasota, Florida, United States
- Marietta, Georgia, United States
- Bridgeton, Missouri, United States
- Paramus, New Jersey, United States
- Greensboro, North Carolina, United States
- Columbus, Ohio, United States
- Hershey, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Chattanooga, Tennessee, United States
- Houston, Texas, United States
- Altenburg, Altenburg, Germany
- Göttingen, Lower Saxony, Germany
- Rhein, Ludwigshafen Am, Germany
- Minden, North Rhine-Westphalia, Germany
- Recklinghausen, Recklinghausen, Germany
- Berlin, State of Berlin, Germany
- Bad Neustadt an der Saale, Germany
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Carmichael, California, United States; Oxnard, California, United States; Sarasota, Florida, United States; Marietta, Georgia, United States; Bridgeton, Missouri, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.