Acute Ischemic StrokePhase 2NCT05399550
Study to Evaluate The Safety and Efficacy of Balovaptan in Participants With Acute Ischemic Stroke at a High Risk of Developing Malignant Brain Edema
A Phase 2 study testing Balovaptan in people with Acute Ischemic Stroke, run by Hoffmann-La Roche at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Balovaptan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 17 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Comprehensive Stroke Care Center
San Francisco, California, 94114
About this study
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
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)
- Conditions
- Acute Ischemic Stroke
- Being tested
- Balovaptan, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalovaptanDrug
Intravenous Solution
PlaceboDrug
Matching Intravenous Solution
| Study group | Role | What they receive |
|---|---|---|
| Balovaptan | Experimental | Balovaptan will be administered as IV infusion once a day over 3 days Receives: Drug: Balovaptan |
| Placebo | Placebo comparator | Placebo will be administered as IV infusion once a day over 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT)
Measured: 72 Hours from Last Known Well
Secondary outcomes (17)
Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4
Measured: At Day 90
Amount of MLS
MLS will be measured in millimeter on NCCT
Measured: At 48 hours and 96-120 hours from LKW
Percentage of Participants with Surgical DHC Performed
Measured: From Baseline up to Day 90
Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment
Measured: From Baseline up to Day 90
National Institute of Health Stroke Scale (NIHSS) score
Measured: At Day 4 and Day 90
Mortality
Mortality in the first 30 days after the enrollment
Measured: At Day 30
mRS-SI score
Measured: At Day 30
Functional Independence Measure (FIM) score
Measured: At Discharge or Day 10 and Day 90
Glasgow Outcome Scale Extended (GOSE) Score
Measured: at Discharge or Day 10, Day 30 and Day 90
Stroke Impact Scale-16 (SIS-16) score
Measured: At Day 30 and Day 90
Length (in days) of ICU and Hospital Stay
Measured: From Baseline to Day 90
Number of participants with adverse events and severity of adverse events
Severity will be determined according to the NCI CTCAE v5.0
Measured: From Baseline to Day 90
Plasma concentrations of balovaptan at specified timepoints
Measured: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)
Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)
As calculated by NCA from measured concentration
Measured: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Maximum observed concentration (Cmax)
As calculated by NCA or taken directly from measured concentration
Measured: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Plasma drug concentration 24hours after the administration of a given dose (C24hr)
As calculated by NCA or taken directly from measured concentration
Measured: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Number of participants with safety findings on brain imaging
Measured: From Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start22 Jun 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399550
- Sponsor's protocol ID
- WC 42759
- Status last verified
- Aug 2023
- First submitted
- 27 May 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05399550
- Acronym / sponsor ID
- WC 42759
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balovaptan | Experimental | Drug: BalovaptanBalovaptan will be administered as IV infusion once a day over 3 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as IV infusion once a day over 3 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BalovaptanIntravenous Solution | Drug | Balovaptan |
| PlaceboMatching Intravenous Solution | Drug | Placebo |
Primary outcome
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)
17 secondary outcomes
Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4
Time frame: At Day 90
Amount of MLS
Time frame: At 48 hours and 96-120 hours from LKW
Percentage of Participants with Surgical DHC Performed
Time frame: From Baseline up to Day 90
Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment
Time frame: From Baseline up to Day 90
National Institute of Health Stroke Scale (NIHSS) score
Time frame: At Day 4 and Day 90
Mortality
Time frame: At Day 30
mRS-SI score
Time frame: At Day 30
Functional Independence Measure (FIM) score
Time frame: At Discharge or Day 10 and Day 90
Glasgow Outcome Scale Extended (GOSE) Score
Time frame: at Discharge or Day 10, Day 30 and Day 90
Stroke Impact Scale-16 (SIS-16) score
Time frame: At Day 30 and Day 90
Length (in days) of ICU and Hospital Stay
Time frame: From Baseline to Day 90
Number of participants with adverse events and severity of adverse events
Time frame: From Baseline to Day 90
Plasma concentrations of balovaptan at specified timepoints
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)
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)]
Maximum observed concentration (Cmax)
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
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)]
Number of participants with safety findings on brain imaging
Time frame: From Baseline to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Balovaptan in people with Acute Ischemic Stroke, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW) (time frame: 72 Hours from Last Known Well). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.