Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke

NCT06648304 | Completed Phase 3 DMC

• 1 other identifier: TTYP01-III-AIS
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with mRS score ≤1 on Day 90 of treatment.

  The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.

  90 days after treatment initiation

Secondary Outcomes (13)

• mRS score on Day 90 of treatment

  90 days after treatment initiation

• Proportion of subjects with mRS score ≤2 on D90 of treatment

  90 days after treatment initiation

• Change from baseline in mRS score on D7, D28, D60 and D90 of treatment

  Baseline and 7, 28, 60, 90 days after treatment initiation

• Change in NIHSS score from baseline on D7, D28 and D90 of treatment

  Baseline and 7, 28, 90 days after treatment initiation

• Proportion of patients with NIHSS score improvement ≥ 4 points on D7, D28, and D90 of treatment

  7, 28 and 90 days after treatment initiation

Study Arms (2)

TTYP01 tablets

EXPERIMENTAL

2 tablets (60 mg) of TTYP01, twice daily, administered 30\~60 minutes before breakfast and dinner

Drug: TTYP01 tablets

Placebo (Simulant TTYP01 Tablets)

PLACEBO COMPARATOR

2 tablets (0 mg) of placebo, twice daily, administered 30\~60 minutes before breakfast and dinner

Drug: Placebo (Simulant TTYP01 Tablets)

Interventions

TTYP01 tablets DRUG

Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (60 mg) of investigational drug each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).

TTYP01 tablets

Placebo (Simulant TTYP01 Tablets) DRUG

Administered 30\~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (0 mg) of placebo each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).

Placebo (Simulant TTYP01 Tablets)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 \~ 80 years (both inclusive);
• Patients diagnosed with acute ischemic stroke according to the 2019AHA/ASA guidelines for ischemic stroke;
• Patients who do not accept suggestions of thrombolysis or thrombectomy or who do not meet the indications for these treatments;
• Patients with symptom onset within ≤ 24 hours; for wake-up strokes or when the exact time of symptom onset cannot be determined due to aphasia or disturbance of consciousness, the last time the patient is seen to be normal shall prevail;
• Patients who are having their first stroke or those who are experiencing a recurrence of stoke after a good recovery (mRS score of 0-1) from their most recent stroke;
• There are clear signs of neurological deficit: 6≤NIHSS score≤20, and also, the sum of NIHSS score for the 5th upper limb and the 6th lower limb is greater than or equal to 2.
• Subjects or their guardians are informed about the study, voluntarily agree to the participation, and provide written informed consent.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Patients with any contraindications (such as metal implants like cardiac pacemakers, claustrophobia, etc.) that prevent them from undergoing CT or MRI examinations;
• Cranial CT or MRI confirmed intracranial hemorrhagic conditions, including but not limited to cerebral hemorrhage, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, and traumatic cerebral hemorrhage; or cases of cerebral infarction with post-infarction hemorrhagic transformation. In cases of minor oozing, the investigator will determine eligibility for enrollment;
• Patients with massive cerebral infarction (low density \> 1/3 of the cerebral hemisphere) as indicated by imaging examinations such as CT or MRI;
• Patients with cerebral infarction accompanied by disturbance of consciousness (NIHSS score Ia \> 1 point), posterior circulation infarction, or transient ischemic attack (TIA);
• Patients with severe mental disorders, depression, or comorbid conditions affecting cognitive function, such as Alzheimer's disease, Parkinson's dementia, or Lewy body dementia, making them unable or unwilling to cooperate with the study;
• Patients who are scheduled for or have received intravenous thrombolysis, or who require endovascular treatment in the immediate or recent future (within 90 days);
• Patients with a history of brain malignant tumors or brain parasitic diseases;
• Patients with a history of severe craniocerebral injury or intracranial infection and an mRS score \> 1 prior to this episode;
• Patients with severe hypertension (systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg) that is uncontrolled by treatment before the first dose;
• Patients with blood glucose levels below 2.7 mmol/L without correction or above 22.2 mmol/L at the time of admission;
• Patients with dysphagia;
• Patients with a history of rheumatic heart disease or atrial fibrillation; those with a heart rate of less than 40 beats per minute or greater than 120 beats per minute; patients with second or third-degree heart block without a pacemaker or other malignant arrhythmias; and patients who have experienced acute myocardial infarction, cardiac intervention, or heart failure within the past 6 months (classified by the New York Heart Association \[NYHA\] as III-IV).
• Patients with other serious systemic or organ diseases that the investigators believe may hinder the evaluation of efficacy or make it unlikely for the patient to complete the expected course of treatment and follow-up (such as malignant tumors with a life expectancy of less than 3 months, etc.).;
• Patients with severe liver and kidney diseases or abnormal renal and liver function tests (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] ≥ 3.0 times the upper limit of normal \[ULN\]; serum creatinine \[Cr\] \> 2.0 times the ULN);

Sponsors & Collaborators

• Shanghai Auzone Biological Technology Co., Ltd.: lead

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yan-Jiang Wang, MD & PhD

  Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: April 25, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

CN (1)