A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke

NCT ID: NCT05301712

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2023-07-10

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naloxone hydrochloride 5.0mg/5ml

Naloxone hydrochloride 60mg (However, the dose may be appropriately increased or decreased according to the judgement of the investigator)

Group Type: EXPERIMENTAL

Naloxone hydrochloride 5.0mg/5ml

Intervention Type: DRUG

• 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

Placebo

Placebo 60ml (However, the dose may be appropriately increased or decreased according to the judgement of the investigator)

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 45mg/5ml

Intervention Type: DRUG

• 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

Interventions

Naloxone hydrochloride 5.0mg/5ml

• 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

Intervention Type: DRUG

Sodium Chloride 45mg/5ml

• 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

Intervention Type: DRUG

Other Intervention Names

Noloxone hydrochloride 5mg; Placebo

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samjin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong Keun Hyun, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Countries

South Korea

Other Identifiers

SJNLX01

Identifier Type: -

Identifier Source: org_study_id