Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema

NCT ID: NCT05399550

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2022-11-17

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 Cerebral Edema (MCE)

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Balovaptan

Balovaptan will be administered as IV infusion once a day over 3 days

Group Type: EXPERIMENTAL

Balovaptan

Intervention Type: DRUG

Intravenous Solution

Placebo

Placebo will be administered as IV infusion once a day over 3 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Intravenous Solution

Interventions

Balovaptan

Intravenous Solution

Intervention Type: DRUG

Placebo

Matching Intravenous Solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

CPMC Comprehensive Stroke Care Center

San Francisco, California, United States

Countries

United States

Other Identifiers

WC 42759

Identifier Type: -

Identifier Source: org_study_id