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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

Awards & highlights

Study Summary

This trial is testing whether a drug called balovaptan is safe and effective for treating people with a certain kind of stroke.

Eligible Conditions

Stroke

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 48 hours and 96-120 hours from lkw

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Amount of MLS

Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)

Functional Independence Measure (FIM) score

+14 more

Side effects data

From 2020 Phase 1 trial • 16 Patients • NCT04156646

Eye Pain

100%

80%

60%

40%

20%

Study treatment Arm

Balovaptan 20 mg Fasted

Balovaptan 20 mg Fasted + Esomeprazole 40 mg Fasted

Balovaptan 20 mg Fed

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

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,089,422 Total Patients Enrolled

1 Trials studying Stroke

5 Patients Enrolled for Stroke

Clinical TrialsStudy DirectorHoffmann-La Roche

2,200 Previous Clinical Trials

888,522 Total Patients Enrolled

2 Trials studying Stroke

318 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research project?

"That is correct, the information on clinicaltrials.gov does show that this research project is recruiting individuals at the current moment. The trial was first posted on 6/22/2022 and has been updated as recently as 10/31/2022. There is a total of 108 participants needed for the study which will be conducted across 1 location."

Answered by AI

Are we able to enroll new patients in this research project?

"According to the most recent update on clinicaltrials.gov, this trial is still actively recruiting patients. This study was originally posted on June 22nd, 2020 and updated as recently as October 31st, 2020."

Answered by AI

Are there any dangers to taking Balovaptan?

"While there is some evidence that Balovaptan may be safe for human use, it has not yet been proven effective. Consequently, it received a score of 2."

Answered by AI

Might I be able to help out with this research by joining the trial?

"This trial is recruiting 108 participants with stroke aged 18 and 80. Most importantly, applicants should meet the following criteria: 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., Document"

Answered by AI

Does this research project have an age limit?

"This particular trial is only for patients between 18-80 years old. There are 78 other trials that cater to patients below the age of 18 and 1,306 studies for individuals who are 65+."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05399550.