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

NCT05399550 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: WC 42759
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)

  Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT)

  72 Hours from Last Known Well

Secondary Outcomes (17)

• Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4

  At Day 90

• Amount of MLS

  At 48 hours and 96-120 hours from LKW

• Percentage of Participants with Surgical DHC Performed

  From Baseline up to Day 90

• Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment

  From Baseline up to Day 90

• National Institute of Health Stroke Scale (NIHSS) score

  At Day 4 and Day 90

Study Arms (2)

Balovaptan

EXPERIMENTAL

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

Drug: Balovaptan

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Balovaptan DRUG

Intravenous Solution

Balovaptan

Placebo DRUG

Matching Intravenous Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

CPMC Comprehensive Stroke Care Center

San Francisco, California, 94114, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

balovaptan

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: June 22, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (1)