Treatment of Acute Ischemic Stroke (ReMEDy II Trial)

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2/3 study to evaluate the safety, tolerability, and efficacy of DM199 in treating acute ischemic stroke patients presenting with AIS and for whom tPA and a catheter-based procedure, MT, are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from onset of stroke (LVO is excluded from this study). The double-blinded study will be randomized, placebo controlled at up to 75 centers.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DiaMedica Therapeutics Inc
• Treatments: Kallikreins

Criteria

Inclusion Criteria:

1. Patient is male or female, ≥18 years of age.

2. Patient has been diagnosed with AIS within the last 24 hours.

• Patient is not a candidate for tPA clinically or outside time window.

• Patient is not a candidate for MT.

3. Patient has NIHSS ≥5 and ≤20.

4. Pre-morbid mRS score of 0-1 (mRS score prior to stroke).

5. Patient and/or legally authorized representative is able to participate in the informed consent process.

6. Patient's ability to comply with the study protocol, in the Investigator's judgment.

Exclusion Criteria:

1. Patient has received or will receive tPA for the current AIS.

2. Patient with imaging findings consistent with LVO.

3. Patient has received MT or is scheduled to have a MT within 24 hours of stroke onset.

4. Patient has had a previous stroke.

5. Patient is currently prescribed ACEi and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 27.

6. Patient has a history of clinically significant allergic diathesis such as urticaria, angioedema or anaphylaxis.

7. Patient with current malignancy or active malignancy ≤1 year prior to enrollment.

Note: except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least 6 months have elapsed since the procedure.

8. Patient has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last 4 weeks prior to enrollment.

9. Patient has clinical or laboratory evidence of an active infection at the time of enrollment.

10. Patient has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).

11. Patient is a pregnant or nursing woman. Note: women who agree to stop nursing may be considered for inclusion at the discretion of the Investigator.

12. Female patients of childbearing potential must use medically acceptable contraceptive measures to prevent pregnancy. All women of childbearing potential (defined as sexually mature women who have had menses within the preceding 24 months and have not undergone hysterectomy, bilateral oophorectomy, etc.) must have a negative pregnancy test performed at screening. Women of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, women must use 2 reliable methods of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period. Male heterosexual patients participating in sexual activity must agree to use 2 reliable methods of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period if their partner is of childbearing potential. A combination of 2 of the following methods must be used:

• Condoms (male or female)

• Diaphragm or cervical cap

• Intra uterine device

• Stable hormonal-based contraception Women who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy) are not required to use contraception.

Male patients will refrain from sperm donation. NOTE: A negative urine pregnancy test will be documented during screening.

13. Patient is participating in any other drug study ≤1 week or 5 half-lives of the investigational product, whichever is longer.

14. Patient does not have sufficient venous access for infusion of study treatment or blood sampling.

15. Patient is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.

16. Patient has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results

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