Clinical trial NCT05301712: A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke
Official title: A Placebo Controlled, Double-blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Naloxone HCl IV in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Acute
Keywords: cerebral infarction or cerebral hemmorrhage
Lead sponsor: Samjin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 446
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Percentage of subjects who have the modified Rankin Scale (mRS) score of 2 or less on Day 90
timeFrame: Day 90
Secondary outcomes:
measure: The change from baseline in Modified Rankin Score (mRS) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in Modified Barthel Index (mBI) up to Day 90.
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in EuroQol five dimensions questionnaire(EQ-5D) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in Korean Mini-Mental State Examination(KMMSE) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in Global Deterioration Scale (GDS) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in National institutes of health stroke scale(NIHSS) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The change from baseline in Glasgow Coma Scale(GCS) up to Day 90
timeFrame: Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90
measure: The odds ratio of the factors which contribute to a mRS score to be less than or equal to 2 on Day 90
timeFrame: Day 90
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Dong Keun Hyun, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: