Neurosensory DisorderPhase 4NCT04509323
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
A Phase 4 study testing Huperzine A for Injection in people with Neurosensory Disorder, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
Trial summary
1. To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage； 2. To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurosensory Disorder
- What is being tested?
- Huperzine A for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to 28 May 2021
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
- First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
- Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
- Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
- The patient/family knows and signs the informed consent form voluntarily.
Who cannot join
- Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
- Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml);
- Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
- Patients who use anticoagulant drugs for a long time;
- Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function;
- The measured value of homocysteine at admission is higher than 15μmol/L;
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- Patients who need surgical treatment (including ventricular drainage);
- Patients with severe primary diseases such as cardiovascular, liver (ALT or AST>1.5 times the upper limit of normal), kidneys (BUN>1.5 times the upper limit of normal and Cr>upper limit of normal), endocrine system and hematopoietic system;
- Those who are allergic to protein and test drugs;
- People who are dependent on drugs or alcohol;
- Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women;
- Participated in other clinical trials within the past 3 months;
- Patients considered by the investigator to be inappropriate to participate in clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 410103
Fu Xudong, PhD, 13733167393, fxd1064@126.com
Zhou Shaolong, PhD, 13838182963, 13838182963@163.com
About this study
Official title: A Randomized, Controlled, Single-center Clinical Study of Huperzine A in the Treatment of Brain Injury in Patients With Hypertensive Cerebral Hemorrhage
- To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage；
- To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。
Read the detailed description
A randomized, controlled, single-center, exploratory clinical research method was used. In the treatment plan, the experimental group used basic treatment + Huperzine A, and the control group only used basic treatment, with a total of 20 cases. To evaluate the effectiveness and safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage.
- Conditions
- Neurosensory Disorder
- Being tested
- Huperzine A for Injection
- Medical subject headings
- Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine A for InjectionDrug
Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental：Huperzine A for Injection+Basic treatment | Experimental | Huperzine A for Injection: Dissolve each bottle with 2ml sterile water for injection and inject into muscle, the course of treatment is 14 days； Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training. Receives: Drug: Huperzine A for Injection |
| Control：Basic treatment | No intervention | Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
At the 90-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Measured: At the 90-day
Secondary outcomes (11)
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
At the 30-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Measured: At the 30-day
Scores of Modified Rankin Scale(mRS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Measured: At the 14-day
Scores of Modified Rankin Scale(mRS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Measured: At the 30-day
Scores of Modified Rankin Scale(mRS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Measured: At the 90-day
Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Measured: At the 14-day
Scores of National Institute of Health stroke scale(NIHSS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Measured: At the 30-day
Scores of National Institute of Health stroke scale(NIHSS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Measured: At the 90-day
Scores of the Barthelindex of ADL at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Measured: At the 14-day
Scores of the Barthelindex of ADL at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Measured: At the 30-day
Scores of the Barthelindex of ADL at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Measured: At the 90-day
Complication rate
After 90 days of treatment, compare whether the incidence of complications (including epilepsy, hydrocephalus, infarction, rebleeding, pneumonia, gastrointestinal hemorrhage) between the two groups is statistically different
Measured: At the 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start3 Aug 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosensory DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with hypertensive basal ganglia cerebral hemorrhage
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509323
- Sponsor's protocol ID
- FM-P5-2020020501
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Single-center Clinical Study of Huperzine A in the Treatment of Brain Injury in Patients With Hypertensive Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04509323
- Acronym / sponsor ID
- FM-P5-2020020501
- Conditions
- Neurosensory Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 May 2021 (estimated)
- First posted
- 12 Aug 2020 (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.
- To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage；
- To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。
Detailed description
A randomized, controlled, single-center, exploratory clinical research method was used. In the treatment plan, the experimental group used basic treatment + Huperzine A, and the control group only used basic treatment, with a total of 20 cases. To evaluate the effectiveness and safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with hypertensive basal ganglia cerebral hemorrhage
| Arm | Type | Receives |
|---|---|---|
| Experimental：Huperzine A for Injection+Basic treatment | Experimental | Drug: Huperzine A for InjectionHuperzine A for Injection: Dissolve each bottle with 2ml sterile water for injection and inject into muscle, the course of treatment is 14 days； Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training. |
| Control：Basic treatment | No intervention | –Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
- First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
- Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
- Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
- The patient/family knows and signs the informed consent form voluntarily.
Key exclusion criteria (13 listed)
- Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
- Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml);
- Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
- Patients who use anticoagulant drugs for a long time;
- Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function;
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 |
|---|---|---|
| Huperzine A for InjectionGive the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days | Drug | Experimental：Huperzine A for Injection+Basic treatment |
Primary outcome
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
Time frame: At the 90-day
At the 90-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
11 secondary outcomes
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
Time frame: At the 30-day
Scores of Modified Rankin Scale(mRS) at 14 days of treatment
Time frame: At the 14-day
Scores of Modified Rankin Scale(mRS) at 30 days of treatment
Time frame: At the 30-day
Scores of Modified Rankin Scale(mRS) at 90 days of treatment
Time frame: At the 90-day
Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment
Time frame: At the 14-day
Scores of National Institute of Health stroke scale(NIHSS) at 30 days of treatment
Time frame: At the 30-day
Scores of National Institute of Health stroke scale(NIHSS) at 90 days of treatment
Time frame: At the 90-day
Scores of the Barthelindex of ADL at 14 days of treatment
Time frame: At the 14-day
Scores of the Barthelindex of ADL at 30 days of treatment
Time frame: At the 30-day
Scores of the Barthelindex of ADL at 90 days of treatment
Time frame: At the 90-day
Complication rate
Time frame: At the 90-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huperzine A for Injection in people with Neurosensory Disorder, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
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 5 inclusion and 13 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 12 Aug 2020. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Fu Xudong, PhD (13733167393, fxd1064@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment (time frame: At the 90-day). 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 12 Aug 2020.