Intracerebral HemorrhagePhase 2ED-ICHNCT04714177
Edaravone Dexborneol for Treatment of Hypertensive Intracerebral Hemorrhage
A Phase 2 study testing Edaravone Dexborneol in people with Intracerebral Hemorrhage, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
pending Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Edaravone Dexborneol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2023
- 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
- Written informed consent from the patient or legally acceptable representative
- Males and females
- Diagnose as hypertensive intracerebral hemorrhage
- Onset of symptoms within 6~48 hours
- Position of bleeding major in basal ganglia
- The sum of scores on items 5 and 6 on the NIHSS were >= 2 at baseline and the total score (items 1-11) was >=6 and <=20
- Volume of Hematoma <= 30 ml
- Premorbid mRS score of 0 or 1
Who cannot join
- Allergy to known study drugs or excipients
- Experienced stroke in latest 3 month
- Volume of Hematoma > 5 ml in other bleeding position
- Obstructive hydrocephalus
- Any diagnosis as other than hypertensive ICH
- Unconsciousness
- Severe concurrent illness with life expectancy less than 90 days
- Pregnancy or breast-feeding
Trial locations and contacts
No sites are listed yet.
Xiaofei Feng, MD contact
About this study
Official title: Efficacy and Safety of Edaravone Dexborneol in Addition to Standard of Care in Patients With Hypertensive Intracerebral Hemorrhage: a Randomized, Double-Blind, Placebo-Controlled Trial
pending
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Edaravone Dexborneol, Placebo
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone DexborneolDrug
Edaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage
PlaceboDrug
Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Edaravone Dexborneol | Experimental | Edaravone Dexborneol injection Receives: Drug: Edaravone Dexborneol |
| Placebo | Placebo comparator | Edaravone Dexborneol matching injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
Measured: 90 days after the first dose of study treatment
Secondary outcomes (6)
The proportion of death
Measured: 90 days after the first dose of study treatment
The proportionof Participants With modified Rankin Scale (mRS)
Measured: 14, 30 and 90 days after the first dose of study treatment
The change in the NIH stroke scale (NIHSS) from the baseline
Measured: 14, 30 and 90 days after the first dose of study treatment
The proportionof Participants With Glasgow Outcome Score (GOS)
Measured: 14, 30 and 90 days after the first dose of study treatment
Barthel Index (BI)
Measured: 90 days after the first dose of study treatment
Stroke Specific Quality of Life Scale (SS-QOL)
Measured: 90 days after the first dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- 390 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714177
- Sponsor's protocol ID
- SIM23-ICH-201
- Acronym
- ED-ICH
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Edaravone Dexborneol in Addition to Standard of Care in Patients With Hypertensive Intracerebral Hemorrhage: a Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04714177
- Acronym / sponsor ID
- ED-ICH / SIM23-ICH-201
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 19 Jan 2021 (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.
pending
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 |
|---|---|---|
| Edaravone Dexborneol | Experimental | Drug: Edaravone DexborneolEdaravone Dexborneol injection |
| Placebo | Placebo comparator | Drug: PlaceboEdaravone Dexborneol matching injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent from the patient or legally acceptable representative
- Males and females
- Diagnose as hypertensive intracerebral hemorrhage
- Onset of symptoms within 6~48 hours
- Position of bleeding major in basal ganglia
Key exclusion criteria (8 listed)
- Allergy to known study drugs or excipients
- Experienced stroke in latest 3 month
- Volume of Hematoma > 5 ml in other bleeding position
- Obstructive hydrocephalus
- Any diagnosis as other than hypertensive ICH
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 |
|---|---|---|
| Edaravone DexborneolEdaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage | Drug | Edaravone Dexborneol |
| PlaceboEdaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage | Drug | Placebo |
Primary outcome
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1
Time frame: 90 days after the first dose of study treatment
6 secondary outcomes
The proportion of death
Time frame: 90 days after the first dose of study treatment
The proportionof Participants With modified Rankin Scale (mRS)
Time frame: 14, 30 and 90 days after the first dose of study treatment
The change in the NIH stroke scale (NIHSS) from the baseline
Time frame: 14, 30 and 90 days after the first dose of study treatment
The proportionof Participants With Glasgow Outcome Score (GOS)
Time frame: 14, 30 and 90 days after the first dose of study treatment
Barthel Index (BI)
Time frame: 90 days after the first dose of study treatment
Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: 90 days after the first dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Xiaofei Feng, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edaravone Dexborneol in people with Intracerebral Hemorrhage, run by First Affiliated Hospital, Sun Yat-Sen University.
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 8 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Feng, MD (+86 18601203770, xiaofeimed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportionof Participants With modified Rankin Scale (mRS) 0 ~ 1 (time frame: 90 days after the first dose of study treatment). 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 19 Jan 2021.