Status:
WITHDRAWN
Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cereb...
Eligibility Criteria
Inclusion
- Diagnosis of LVO in the anterior circulation such that study drug administration can be initiated within 12 hours of LKW and at risk of MCE development, as defined as follows:
- Documented occlusion of terminus ICA and/or MCA on CTA or magnetic resonance angiogram and
- ASPECTS score \</=5 on NCCT and
- NIHSS \>15 for the non-dominant hemisphere and \>20 for the dominant hemisphere (or \> 20 if dominant/non-dominant hemisphere unknown)
- Present with a WUS \</=8 hours from awakening provided the above criteria are met
- Participants with a history of seizures on anti-epileptic medications may be included if they have been on stable doses of those medications for at least 12 weeks prior to LKW, they have not experienced seizures during that time frame, and their anti-epileptic medicines are continued during the study
- For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs
- No specific contraception methods for males are required.
Exclusion
- Participants who are \>12 hours from LKW at the start of treatment with study drug or \>8 hours from awakening with WUS
- Any MLS on brain imaging
- Evidence of intracranial hemorrhage at screening based on NCCT
- Contraindication to MRI examination
- Evidence of additional anterior cerebral artery (ACA) infarction
- Diagnosis of brain death
- Planned surgical decompression prior to randomization
- Participants with a known history of a hereditary bleeding disorder which increases bleeding risk
- Chronic kidney disease stage III or higher
- Hepatic injury
- Diagnosis of diabetes insipidus
- Participants who have received any prophylactic hyperosmolar therapy
- Participants who have received treatment with any other V1a and/or V2 receptor-blocking agent or glyburide
- A preexisting medical condition for which the participant is unlikely to survive the next 6 months
- Planned limitation or withdrawal of life-sustaining treatment during hospital admission
- Participants who are pregnant or breastfeeding, or intending to become pregnant
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05399550
Start Date
June 22 2022
End Date
November 17 2022
Last Update
August 7 2023
Active Locations (1)
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1
CPMC Comprehensive Stroke Care Center
San Francisco, California, United States, 94114