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Vasopressin V1a Receptor Antagonist

Balovaptan for Stroke

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours and 96-120 hours from lkw

Summary

This trial is testing a drug called balovaptan to see if it can help people who have had a stroke and are at risk of severe brain swelling. The goal is to find out if the drug is safe and effective in preventing or reducing this swelling.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours and 96-120 hours from lkw
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours and 96-120 hours from lkw for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
Secondary study objectives
Amount of MLS
Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)
Maximum observed concentration (Cmax)
+3 more

Side effects data

From 2023 Phase 2 trial • 29 Patients • NCT05401565
15%
Overdose
8%
Meniscus injury
8%
Gout
8%
Hypercholesterolaemia
8%
Constipation
8%
Nausea
8%
COVID-19
8%
Seasonal allergy
8%
Joint swelling
8%
Pharyngitis streptococcal
8%
Abnormal dreams
8%
Anxiety
8%
Dizziness
8%
Dysmenorrhoea
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
PLACEBO
BALOVAPTAN 10 MG

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BalovaptanExperimental Treatment1 Intervention
Balovaptan will be administered as IV infusion once a day over 3 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered as IV infusion once a day over 3 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balovaptan
2022
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,097,612 Total Patients Enrolled
1 Trials studying Stroke
5 Patients Enrolled for Stroke
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
896,360 Total Patients Enrolled
2 Trials studying Stroke
318 Patients Enrolled for Stroke
~0 spots leftby Nov 2025
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