Assessing Sovateltide for Treating Acute Cerebral Ischemic Stroke
A Prospective, Multicentric, Randomized, Double-blind, Parallel, Phase IV Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
PHASE4 · Pharmazz, Inc. · NCT05955326
This study is testing a new treatment called sovateltide to see if it can help people recover better after having an acute cerebral ischemic stroke.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | Pharmazz, Inc. (industry) |
| Locations | 6 sites (Guntur, Andhra Pradesh and 5 other locations) |
| Trial ID | NCT05955326 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of sovateltide, a treatment aimed at enhancing brain repair after acute cerebral ischemic stroke. It is a multicenter, randomized, double-blind, phase IV trial involving 160 patients who will receive either sovateltide or normal saline alongside standard treatment. The study focuses on the drug's ability to promote neuronal regeneration and increase blood flow in the brain, potentially improving recovery outcomes. Patients will be monitored over a period of three months following treatment to assess the drug's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 78 who have experienced an ischemic stroke within the last 24 hours and meet specific clinical criteria.
Not a fit: Patients with hemorrhagic strokes or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and outcomes for patients suffering from acute cerebral ischemic stroke.
How similar studies have performed: While this approach is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult males or females aged 18 years through 78 years (have not had their 79th birthday) * Patient or Legally Acceptable Representative (LAR) willing to give informed consent before study procedure. * Stroke is ischemic in origin and radiologically confirmed Computed Tomography (CT) scan or diagnostic magnetic resonance imaging (MRI) before enrolment. No hemorrhage as proved by cerebral CT/MRI scan. * Cerebral ischemic stroke patients presenting within 24 hours after onset of symptoms with mRS score of 3-4 (pre-stroke mRS score of 0 or 1) and NIHSS score \>5 (NIHSS Level of Consciousness (1A) score must be \< 2). This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke. * The patient is \<24 hours from the time of stroke onset when the first dose of Sovateltide therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when the patient was last seen or was self-reported to be normal. * Reasonable expectation of availability to receive the full Sovateltide course of therapy and to be available for subsequent follow-up visits. 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 ≥ 2). * Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, an acute or chronic subdural hematoma on the baseline CT or MRI scan 4. Known pregnancy. * Confounding pre-existing neurological or psychiatric disease. * 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 might cause harm to the patient.
Where this trial is running
Guntur, Andhra Pradesh and 5 other locations
- Guntur Medical College and Government General Hospital — Guntur, Andhra Pradesh, India (RECRUITING)
- Lalitha Super Specialities Hospital Pvt. Ltd. — Guntur, Andhra Pradesh, India (RECRUITING)
- Radiant Superspeciality Hospital — Amravati, Maharashtra, India (RECRUITING)
- Government Medical College and attached Hospitals — Kota, Rajasthan, India (RECRUITING)
- KG Hospital and Post Graduate Medical Institute — Coimbatore, Tamil Nadu, India (RECRUITING)
- Maharani Laxmibai Medical College — Jhānsi, Uttar Pradesh, India (RECRUITING)
Study contacts
- Study coordinator: Dharmesh Shah, Dr.
- Email: dharmesh.shah@pharmazz.com
- Phone: +91(120)256-9779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Cerebral Ischemia, Stroke, Endothelin, Endothelin B Receptors, Ischemia, IRL 1620, Sovateltide, Neural progenitors