The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke

NCT04453800 | Completed Phase 2

• 1 other identifier: PUTH2017013
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke

Conditions

Acute Ischemic Stroke

Keywords

Sofadil; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with a NIHSS score

  Proportion of subjects with a NIHSS score of 0 \~ 1 or 4 or more points less than baseline NIHSS at 14±2 days of treatment

  14±2 days of treatment

Secondary Outcomes (1)

• Changes in NIHSS score

  at 14±2, 30±2, and 90±7 days after treatment compared to baseline

Study Arms (4)

Group A ：low dose sofadil

EXPERIMENTAL

500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours

Drug: sofadil【Neu2000KW】

Group B: Medium dose group

EXPERIMENTAL

750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours

Drug: Sofadil

Group C: high dose group

EXPERIMENTAL

1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours

Drug: Sofadil

Group D: placebo group

PLACEBO COMPARATOR

Saline was administered intravenously

Other: placebo

Interventions

sofadil【Neu2000KW】 DRUG

500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours

Also known as: low dose

Group A ：low dose sofadil

Sofadil DRUG

750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours

Also known as: Medium dose

Group B: Medium dose group

placebo OTHER

Saline was administered intravenously

Group D: placebo group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The target population is 35-75 years old, regardless of gender;
• within 6h of onset, ischemic stroke of the internal carotid artery system;
• Neurological deficits, including limb weakness, with acute brain injury (NIHSS score) (4-22 points), or NIHSS item 5 upper limb or 6 lower limb score ≥2 points;
• Be able to initiate study treatment within 6 hours of onset of symptoms or within 6 hours of last appearing normal (6 hours after sleep in subjects with ischemic stroke who developed during sleep) and complete post-onset CT examination prior to study treatment;
• Obtain the informed consent signed by the subject or the subject's legal representative;
• MRS score before onset was 0\~1;
• Patients with no history of myocardial infarction within 3 months;
• Centerless, liver, kidney and lung dysfunction;
• No hemorrhagic disease within 3 months;
• No blood system diseases.

You may not qualify if:

• Any contraindications to CT or MRI (such as metal implants such as pacemaker, claustrophobia, etc
• Stroke caused by posterior circulation ischemia, or TIA;
• Acute intracranial hemorrhage, intracranial tumor, subarachnoid hemorrhage, encephalitis or other non-acute ischemic stroke (onset less than 6 hours), intracranial arteriovenous malformations;
• Patients who plan to undergo endovascular treatment, such as mechanical thrombectomy, stenting or arteriovenous bridging, within 6 hours after onset;
• Pregnant or lactating women. Note: The blood pregnancy test for fertile women before randomization must be negative and appropriate contraception should be used at least 3 weeks before randomization until 7 days after study drug infusion
• A pre-existing medical, neurological or psychiatric disorder that confuses neurological, functional or imaging assessments, such as persistent injury from previous ischemic stroke;
• Patients with malignant tumors or other critical diseases;
• Having a history of epilepsy or having epileptiform symptoms at the onset of stroke;
• Previous history of intracranial hemorrhage;
• Patients with previous hypotension or blood pressure of less than 90/60mmhg measured for 3 consecutive times;
• Patients with severe injuries and surgical history within 3 months;
• People with consciousness disorder can be defined as "NIHSS score Ia ≥2 points";
• Bradycardia with complete atrioventricular block;
• According to the New York heart association (NYHA) grade of cardiac function, cardiac function rating above Ⅱ level, a history of congestive heart failure (CHF).
• Patients with primary liver and kidney diseases, AST or ALT twice as high as the normal upper limit, serum creatinine \>2.0 mg/dL or \>176.8 mol/L;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dongsheng Fan

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Dongsheng Fan, MD.PHD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will be conducted in a double-blind form. The clinical research team participating in the study will be divided into two groups: blind and non-blind members, strictly ensuring that researchers and subjects are blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 1, 2020
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)