Balovaptan for Stroke

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CPMC Comprehensive Stroke Care Center, San Francisco, CA
Stroke+4 More
Balovaptan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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)

Eligible Conditions

  • Stroke
  • Stroke, Acute, Stroke Ischemic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: At 48 hours and 96-120 hours from LKW

Hour 72
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
Hour 120
Amount (in millimeters) of MLS
At Day 30
Mortality
mRS-SI score
Day 90
Stroke Impact Scale-16 (SIS-16) score
Day 90
National Institute of Health Stroke Scale (NIHSS) score
At Day 90
Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4
Day 90
Functional Independence Measure (FIM) score
Hour 120
Plasma concentrations of balovaptan at specified timepoints
Hour 120
Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)
Maximum observed concentration (Cmax)
Plasma drug concentration 24hours after the administration of a given dose (C24hr)
Day 90
Length (in days) of ICU and Hospital Stay
Number of participants with adverse events and severity of adverse events
Number of participants with safety findings on brain imaging
Day 4
Glasgow Coma Scale (GCS) Score
Day 90
Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment
Percentage of Participants with Surgical DHC Performed

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted
6%Gastroenteritis
6%Tooth fracture
0%Eye Pain
0%Headache
This histogram enumerates side effects from a completed 2020 Phase 1 trial (NCT04156646) in the Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted ARM group. Side effects include: Gastroenteritis with 6%, Tooth fracture with 6%, Eye Pain with 0%, Headache with 0%.

Trial Design

2 Treatment Groups

Balovaptan
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

108 Total Participants · 2 Treatment Groups

Primary Treatment: Balovaptan · Has Placebo Group · Phase 2

Balovaptan
Drug
Experimental Group · 1 Intervention: Balovaptan · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balovaptan
2018
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 48 hours and 96-120 hours from lkw
Closest Location: CPMC Comprehensive Stroke Care Center · San Francisco, CA
Photo of San Francisco  1Photo of San Francisco  2Photo of San Francisco  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Stroke
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
No specific contraception methods for females are required.
You have a score of <5 on the ASPECTS test.
Documented occlusion of terminus ICA and/or MCA on CTA or magnetic resonance angiogram.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.