Trial · NCT05399550
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NCT05399550, Phase 2, Withdrawn, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema. Trials, record NCT05399550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05399550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema
- NCT number
- NCT05399550
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Acute Ischemic Stroke
- Interventions
- Balovaptan, Placebo
- First posted
- 2022-06-01
- Last updated
- 2023-08-07
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW) | 72 Hours from Last Known Well | Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT) |
| Secondary | Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4 | At Day 90 | |
| Secondary | Amount of MLS | At 48 hours and 96-120 hours from LKW | MLS will be measured in millimeter on NCCT |
| Secondary | Percentage of Participants with Surgical DHC Performed | From Baseline up to Day 90 | |
| Secondary | Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment | From Baseline up to Day 90 | |
| Secondary | National Institute of Health Stroke Scale (NIHSS) score | At Day 4 and Day 90 | |
| Secondary | Mortality | At Day 30 | Mortality in the first 30 days after the enrollment |
| Secondary | mRS-SI score | At Day 30 | |
| Secondary | Functional Independence Measure (FIM) score | At Discharge or Day 10 and Day 90 | |
| Secondary | Glasgow Outcome Scale Extended (GOSE) Score | at Discharge or Day 10, Day 30 and Day 90 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05399550
GET https://conductscience.org/api/trials/v1/NCT05399550/registered