Stroke, AcutePhase 4NCT05301712
A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke
A Phase 4 study testing Naloxone hydrochloride 5.0mg/5ml and Sodium Chloride 45mg/5ml in people with Stroke, Acute, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage. Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at 1:1 ratio. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Naloxone hydrochloride 5.0mg/5ml and Sodium Chloride 45mg/5ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2018to 10 Jul 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are males or females aged ≥19 years
- Patients with a stroke who can administer drugs for clinical trials within 48 hours from stroke onset
- Patients with a NIHSS score of 5-20 or GCS score of 8-13 at screening assessment (In the case of cerebral infarction, the NIHSS is evaluated, and cerebral hemorrhage, the GCS is evaluated.)
- Patients with a mRS(Modified Rankin Score) > 2 after stroke and immediately before randomization.
- Patients who or whose representative voluntarily agrees to this study and has given a written informed consent.
Who cannot join
- Subjects with medical history of hypersensitivity reaction to investigational product or ingredients.
- Patients with non-narcotic central nerve inhibitors such as barbital drugs or respiratory depression caused by pathological causes.
- Patients who have not passed the wash-out time after administration of opioid analgesics.
- Subjects with Renal dysfunction whose creatine level is more than twice the normal upper limit in screening tests
- Subjects with Liver dysfunction whose AST/ALT level is more than three times the normal upper limit in screening tests.
- Subjects with Systolic blood pressure less than 90 mmHg or more than 220 mmHg during screening.
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- Patients with a mRS > 2 before stroke onset.
- Patients with a history of epilepsy.
- Patients with myocardial infarction within 1 month.
- Pregnant or lactating women
- Patients who have passed more than 48 hours since the onset of symptoms.
- Subjects who received other therapeutic investigational product within the last 30 days.
- Patients who transient ischemic attack.
- Patients whose life expectancy is less than 3 months due to comorbidities other than stroke
- Thrombolysis (including non-drug treatments such as thrombolytic drugs and mechanical procedures used in thrombolysis) or extraventricular drainage (surgical treatment) has been performed or is scheduled to be performed.
- Thrombolytic agent used in thrombolysis[ex. Streptokinase, Alteplase, Anistreplase, Urokinase, Reteplase, Tenecteplase, Tissue-plasminogen activator (t-PA), Single-chain urokinase-type plasminogen activator (Scu-PA), Lanoteplase, Monteplase, Plasminogen activator inhibitors (PAI)]
- Surgical treatment [ex. mechanical thrombectomy, external ventricular drainage (EVD), extralesional drainage (ELD), decompression], Subarachnoid hemorrhage (SH), Trauma patients [ex. SH coiling, traumatic intracranial hemorrhage (ICH)], Among patients with infarction, patients who need or are scheduled to perform Depressive craniomy.
- Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo Controlled, Double-blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Naloxone HCl IV in Patients With Stroke
This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage.
Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at 1:1 ratio.
Read more
Also, factors, such as disease subtype and severity, which might impact the efficacy endpoints will be used to stratify.
- Stratification factor: cerebral infarction (NIHSS 5-15 points or 16-20 points) or cerebral hemorrhage
Administration of investigational product should be started within 48 hours from the onset of symptoms.
Subject receive the investigational product 7 consecutive times (for 7 days) in a single dose of intravenous infusion for 24 hours.
- Conditions
- Stroke, Acute
- Being tested
- Naloxone hydrochloride 5.0mg/5ml, Sodium Chloride 45mg/5ml
- Keywords
- cerebral infarction or cerebral hemmorrhage
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone hydrochloride 5.0mg/5mlDrug
Also called Noloxone hydrochloride 5mg
- Initial dose: 4mg, Intravenous injection
- Continuous dose: 8mg(mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days
- Total dose: 4mg+8mg/day*7=60mg
Sodium Chloride 45mg/5mlDrug
Also called Placebo
- Initial dose: 4ml, Intravenous injection
- Continuous dose: 8ml (mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days
- Total dose: 4ml+8ml/day*7=60ml
| Study group | Role | What they receive |
|---|---|---|
| Naloxone hydrochloride 5.0mg/5ml | Experimental | Naloxone hydrochloride 60mg (However, the dose may be appropriately increased or decreased according to the judgement of the investigator) Receives: Drug: Naloxone hydrochloride 5.0mg/5ml |
| Placebo | Placebo comparator | Placebo 60ml (However, the dose may be appropriately increased or decreased according to the judgement of the investigator) Receives: Drug: Sodium Chloride 45mg/5ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90
Modified Rankin Scale is an index that evaluates the patient's global functional outcome according to the independence of daily life and the degree of need for help from others. It is evaluated in seven stages (0 to 6 points), from asymptomatic to death. The higher score means a worse outcome, and 3 to 6 points are considered to be poor functional outcome.
Measured: Day 90
Secondary outcomes (8)
The change from baseline in Modified Rankin Score (mRS) up to Day 90
Modified Rankin Scale is an index that evaluates the patient's global functional outcome according to the independence of daily life and the degree of need for help from others. It is evaluated in seven stages (0 to 6 points), from asymptomatic to death. The higher score means a worse outcome, and 3 to 6 points are considered to be poor functional outcome.
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Modified Barthel Index (mBI) up to Day 90.
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in EuroQol five dimensions questionnaire(EQ-5D) up to Day 90
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Korean Mini-Mental State Examination(KMMSE) up to Day 90
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Global Deterioration Scale (GDS) up to Day 90
The GDS is a staging scale indicating deterioration in dementia, The scale details clinical descriptions of seven major distinguishable stages, ranging from normal cognition to severe dementia.
Stages 1 - 3 are the pre dementia stages. Stages 4 -7 reflect the stages of dementia. People beginning with stage 5 are no longer survive without assistance.
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in National institutes of health stroke scale(NIHSS) up to Day 90
It will be evaluated in patients with cerebral infarction.
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke.
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4.
For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
The individual scores from each item are summed in order to calculate a patient's total NIHSS score.
The maximum possible score is 42, with the minimum score being a 0.
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Glasgow Coma Scale(GCS) up to Day 90
It will be evaluated in patients with cerebral hemorrhage. The Glasgow Coma Scale (GCS) is used to objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients.
The Glasgow Coma Scale divides into three parameters: best eye response (E), best verbal response (V) and best motor response (M). The levels of response in the components of the Glasgow Coma Scale are 'scored' from 1, for no response, up to normal values of 4 (Eye-opening response) 5 ( Verbal response) and 6 (Motor response) The total Coma Score thus has values between three and 15, three being the worst and 15 being the highest.
Measured: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The odds ratio of the factors which contribute to a mRS score to be less than or equal to 2 on Day 90
The factors, such as sex, age, disease subtype and severity, investigational product compliance, which might impact the mRS score to be less than or equal to 2 will be analyzed.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Aug 2018
- Primary completion25 Oct 2022
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- This clinical trial was planned for the purpose of re-evaluating ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage the efficacy and effects of naloxone hydrochloride.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Keun Hyun, M.D.,Ph.D, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301712
- Sponsor's protocol ID
- SJNLX01
- Status last verified
- Aug 2023
- First submitted
- 11 Mar 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double-blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Naloxone HCl IV in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05301712
- Acronym / sponsor ID
- SJNLX01
- Conditions
- Stroke, Acute
- Keywords
- cerebral infarction or cerebral hemmorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 31 Mar 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 clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage.
Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at 1:1 ratio.
Also, factors, such as disease subtype and severity, which might impact the efficacy endpoints will be used to stratify.
- Stratification factor: cerebral infarction (NIHSS 5-15 points or 16-20 points) or cerebral hemorrhage
Administration of investigational product should be started within 48 hours from the onset of symptoms.
Subject receive the investigational product 7 consecutive times (for 7 days) in a single dose of intravenous infusion for 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical trial was planned for the purpose of re-evaluating ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage the efficacy and effects of naloxone hydrochloride.
| Arm | Type | Receives |
|---|---|---|
| Naloxone hydrochloride 5.0mg/5ml | Experimental | Drug: Naloxone hydrochloride 5.0mg/5mlNaloxone hydrochloride 60mg (However, the dose may be appropriately increased or decreased according to the judgement of the investigator) |
| Placebo | Placebo comparator | Drug: Sodium Chloride 45mg/5mlPlacebo 60ml (However, the dose may be appropriately increased or decreased according to the judgement of the investigator) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are males or females aged ≥19 years
- Patients with a stroke who can administer drugs for clinical trials within 48 hours from stroke onset
- Patients with a NIHSS score of 5-20 or GCS score of 8-13 at screening assessment (In the case of cerebral infarction, the NIHSS is evaluated, and cerebral hemorrhage, the GCS is evaluated.)
- Patients with a mRS(Modified Rankin Score) > 2 after stroke and immediately before randomization.
- Patients who or whose representative voluntarily agrees to this study and has given a written informed consent.
Key exclusion criteria (18 listed)
- Subjects with medical history of hypersensitivity reaction to investigational product or ingredients.
- Patients with non-narcotic central nerve inhibitors such as barbital drugs or respiratory depression caused by pathological causes.
- Patients who have not passed the wash-out time after administration of opioid analgesics.
- Subjects with Renal dysfunction whose creatine level is more than twice the normal upper limit in screening tests
- Subjects with Liver dysfunction whose AST/ALT level is more than three times the normal upper limit in screening tests.
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 |
|---|---|---|
| Naloxone hydrochloride 5.0mg/5mlAlso: Noloxone hydrochloride 5mg* Initial dose: 4mg, Intravenous injection * Continuous dose: 8mg(mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days * Total dose: 4mg+8mg/day*7=60mg | Drug | Naloxone hydrochloride 5.0mg/5ml |
| Sodium Chloride 45mg/5mlAlso: Placebo* Initial dose: 4ml, Intravenous injection * Continuous dose: 8ml (mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days * Total dose: 4ml+8ml/day*7=60ml | Drug | Placebo |
Primary outcome
Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90
Time frame: Day 90
Modified Rankin Scale is an index that evaluates the patient's global functional outcome according to the independence of daily life and the degree of need for help from others. It is evaluated in seven stages (0 to 6 points), from asymptomatic to death. The higher score means a worse outcome, and 3 to 6 points are considered to be poor functional outcome.
8 secondary outcomes
The change from baseline in Modified Rankin Score (mRS) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Modified Barthel Index (mBI) up to Day 90.
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in EuroQol five dimensions questionnaire(EQ-5D) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Korean Mini-Mental State Examination(KMMSE) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Global Deterioration Scale (GDS) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in National institutes of health stroke scale(NIHSS) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The change from baseline in Glasgow Coma Scale(GCS) up to Day 90
Time frame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
The odds ratio of the factors which contribute to a mRS score to be less than or equal to 2 on Day 90
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
Dong Keun Hyun, M.D.,Ph.D principal investigator
Inha University Hospital
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 Naloxone hydrochloride 5.0mg/5ml and Sodium Chloride 45mg/5ml in people with Stroke, Acute, run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 18 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: finished, as of the sponsor's last update on 14 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 South Korea. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90 (time frame: Day 90). 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 14 Aug 2023.