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

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ClinicalTrials.gov Identifier: NCT05399550
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Balovaptan Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate The Safety and Efficacy of Balovaptan in Patients With Acute Ischemic Stroke at High Risk of Developing Malignant Cerebral Edema
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : June 27, 2024
Estimated Study Completion Date : June 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Balovaptan
Balovaptan will be administered as IV infusion once a day over 3 days
 Drug: Balovaptan
Intravenous Solution
Placebo Comparator: Placebo
Placebo will be administered as IV infusion once a day over 3 days
 Drug: Placebo
Matching Intravenous Solution


Outcome Measures
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Primary Outcome Measures :
  1. Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW) [ Time Frame: 72 Hours from Last Known Well ]
    Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT)


Secondary Outcome Measures :
  1. Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4 [ Time Frame: At Day 90 ]
  2. Amount of MLS [ Time Frame: At 48 hours and 96-120 hours from LKW ]
    MLS will be measured in millimeter on NCCT

  3. Percentage of Participants with Surgical DHC Performed [ Time Frame: From Baseline up to Day 90 ]
  4. Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment [ Time Frame: From Baseline up to Day 90 ]
  5. National Institute of Health Stroke Scale (NIHSS) score [ Time Frame: At Day 4 and Day 90 ]
  6. Mortality [ Time Frame: At Day 30 ]
    Mortality in the first 30 days after the enrollment

  7. mRS-SI score [ Time Frame: At Day 30 ]
  8. Functional Independence Measure (FIM) score [ Time Frame: At Discharge or Day 10 and Day 90 ]
  9. Glasgow Outcome Scale Extended (GOSE) Score [ Time Frame: at Discharge or Day 10, Day 30 and Day 90 ]
  10. Stroke Impact Scale-16 (SIS-16) score [ Time Frame: At Day 30 and Day 90 ]
  11. Length (in days) of ICU and Hospital Stay [ Time Frame: From Baseline to Day 90 ]
  12. Number of participants with adverse events and severity of adverse events [ Time Frame: From Baseline to Day 90 ]
    Severity will be determined according to the NCI CTCAE v5.0

  13. Plasma concentrations of balovaptan at specified timepoints [ Time Frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge) ]
  14. Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr) [ Time Frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] ]
    As calculated by NCA from measured concentration

  15. Maximum observed concentration (Cmax) [ Time Frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] ]
    As calculated by NCA or taken directly from measured concentration

  16. Plasma drug concentration 24hours after the administration of a given dose (C24hr) [ Time Frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)] ]
    As calculated by NCA or taken directly from measured concentration

  17. Number of participants with safety findings on brain imaging [ Time Frame: From Baseline to Day 90 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399550


Contacts
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Contact: Reference Study ID Number: WC 42759 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, California
CPMC Comprehensive Stroke Care Center Recruiting
San Francisco, California, United States, 94114
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05399550    
Other Study ID Numbers: WC 42759
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Balovaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs