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

NCT05301712 | Completed Phase 4

• 1 other identifier: SJNLX01
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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

Keywords

cerebral infarction or cerebral hemmorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 90

Secondary Outcomes (8)

• The change from baseline in Modified Rankin Score (mRS) up to Day 90

  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.

  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

  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

  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

  Baseline, Day 3, Day 7, Day 14(or discharge), Day 30 and Day 90

Study Arms (2)

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)

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)

Drug: Sodium Chloride 45mg/5ml

Interventions

Naloxone hydrochloride 5.0mg/5ml 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

Also known as: Noloxone hydrochloride 5mg

Naloxone hydrochloride 5.0mg/5ml

Sodium Chloride 45mg/5ml 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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction

Interventions

Naloxone; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dong Keun Hyun, M.D.,Ph.D

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: August 7, 2018
• Primary Completion: October 25, 2022
• Study Completion: July 10, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

KR (1)