GD-11 for Injection in the Treatment of Acute Ischemic Stroke

NCT06299579 | Recruiting Phase 3

• 1 other identifier: WG-GD11-III-01
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 2

Brief Summary

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.

Conditions

Acute Ischemic Stroke

Keywords

Subjects within 48 hours

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with mRS score ≤1 on 90th day of treatment

  Proportion of subjects with mRS score ≤1 on 90th day of treatment

  on 90th day of treatment

Study Arms (2)

GD-11 for injection test group

EXPERIMENTAL

GD-11 for injection, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min. The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.

Drug: GD-11 for injection test group

Placebo control group

PLACEBO COMPARATOR

Placebo, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min. The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.

Drug: Placebo control group

Interventions

GD-11 for injection test group DRUG

The first dose of GD-11 was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

GD-11 for injection test group

Placebo control group DRUG

The first dose of placebo was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Placebo control group

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only those who meet all of the following items will be enrolled:
• age ≥18 years and \<81 years, male or female;
• National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event;
• The onset of the disease is within 48 hours (including 48 hours);
• Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset);
• Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.

You may not qualify if:

• Those who met one of the following items at screening will not be eligible for enrollment:
• intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment;
• severe impairment of consciousness: item score \>1 on the 1a level of consciousness of the NIHSS;
• thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode;
• transient ischemic attack (TIA);
• the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control;
• patients with a previous diagnosis of severe mental disorders as well as patients with dementia;
• patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT (Alanine amino Transferase) or AST (Aspartate amino Transferase) \> 2.0 x ULN (Upper Limit of Normal Value);
• patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine \> 1.5 × ULN;
• after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran edaravone/(+)-2-Decanol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oxiracetam, butylphenyl peptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on.
• previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes;
• previously diagnosed with a serious systemic disease with an expected survival of \<90 days;
• the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period
• patients with a previously known hypersensitivity to GD-11 for Injection and its excipients;
• history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Jiangsu Wangao Pharmaceutical Co. ltd: collaborator

Study Sites (2)

Beijing Tiantan Hospital Capital Medical University Beijing

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Linfen Central Hospital

Shangxi, Linfen City, 041099, China

RECRUITING

Related Publications (5)

• Motwani JG, Lipworth BJ. Clinical pharmacokinetics of drug administered buccally and sublingually. Clin Pharmacokinet. 1991 Aug;21(2):83-94. doi: 10.2165/00003088-199121020-00001. No abstract available.

  PMID: 1884569 RESULT

• Sato T, Mizuno K, Ishii F. A novel administration route of edaravone--II: mucosal absorption of edaravone from edaravone/hydroxypropyl-beta-cyclodextrin complex solution including L-cysteine and sodium hydrogen sulfite. Pharmacology. 2010;85(2):88-94. doi: 10.1159/000276548. Epub 2010 Jan 21.

  PMID: 20110753 RESULT

• Enlimomab Acute Stroke Trial Investigators. Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial. Neurology. 2001 Oct 23;57(8):1428-34. doi: 10.1212/wnl.57.8.1428.

  PMID: 11673584 RESULT

• Cui L, Hung HM, Wang SJ. Modification of sample size in group sequential clinical trials. Biometrics. 1999 Sep;55(3):853-7. doi: 10.1111/j.0006-341x.1999.00853.x.

  PMID: 11315017 RESULT

• Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med. 2011 Dec 10;30(28):3267-84. doi: 10.1002/sim.4102. Epub 2010 Nov 30.

  PMID: 22105690 RESULT

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

• Shuya Li

  IRB of Beijing Tiantan Hospital Capital Medical University Beijing

  STUDY DIRECTOR

Central Study Contacts

Yongjun Wang

CONTACT

+86 10 5997 8538; yongjunwang111@aliyun.com

Shuya Li

CONTACT

13601367028; shuyali85@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This trial is designed as a multicenter, randomized, double-blind, placebo-parallel controlled trial using a multicenter, randomized, double-blind, placebo-parallel controlled trial design. Subjects are randomly assigned in a 1:1 ratio and random number tables are generated using SAS（Statistics Analysis System）software.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 8, 2024
• Study Start: February 29, 2024
• Primary Completion: February 22, 2025
• Study Completion: December 31, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)