Redasemtide for Stroke

(REvive Trial)

Recruiting in Palo Alto (17 mi)

+187 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Shionogi

Disqualifiers: Severe consciousness decrease, Recent stroke, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called redasemtide to see if it can help adults who have had a stroke. The goal is to find out if this medication can protect brain cells and help them heal better after the stroke. Researchers are looking at both how well it works and if it is safe to use.

Will I have to stop taking my current medications?

The trial protocol mentions that certain medications or therapies are prohibited for the treatment of the current stroke, but it does not specify which ones. It's best to discuss your current medications with the study team to see if any changes are needed.

What makes the drug Redasemtide unique for treating stroke?

The drug Redasemtide is unique for treating stroke because it is specifically designed for this condition, whereas many existing treatments for stroke focus on managing symptoms or preventing further strokes rather than directly addressing the underlying damage. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adults who've had an ischemic stroke within the last 25 hours and are not suitable for clot removal treatments. They should have a moderate level of stroke severity, be medically stable except for their stroke, and likely to complete the study without needing hospitalization.

Inclusion Criteria

My doctor says I can't have treatments to reopen my blood vessels.

My stroke severity score is between 8 and 22 and hasn't changed recently.

I can start the study treatment within 25 hours after my stroke.

Exclusion Criteria

Blood glucose level < 50 or > 400 milligrams/deciliter after glycemic control

Participants who have received any investigational product within 90 days of screening

Unable to undergo either CT or MRI

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Redasemtide or placebo is administered as an IV infusion once daily for 5 consecutive days during hospitalization

1 week

5 visits (in-person, during hospitalization)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Redasemtide (Other)

Trial Overview The trial is testing Redasemtide's effectiveness and safety in treating acute ischemic strokes compared to a placebo. Participants will randomly receive either Redasemtide or a placebo without knowing which one they're getting (double-blind).

Participant Groups

Group I: Redasemtide Dose B Experimental Treatment 1 Intervention

Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.

Group II: Redasemtide Dose A Experimental Treatment 1 Intervention

Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.

Group III: Placebo Placebo Group 1 Intervention

Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Findings from Research

A phase I-II study involving 27 patients with advanced or recurrent cervical cancer showed that the combination of irinotecan (CPT-11) and nedaplatin (254-S) resulted in a promising overall response rate of 59%, with 7% achieving complete responses and 52% partial responses.

The maximum tolerated doses were determined to be 60 mg/m² for CPT-11 and 80 mg/m² for nedaplatin, with manageable toxicity; 67% of patients experienced grade 3/4 hematologic toxicity, but non-hematologic toxicities were mostly mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I-II study of irinotecan (CPT-11) plus nedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrent cervical cancer. Tsuda, H., Hashiguchi, Y., Nishimura, S., et al.[2022]

A phase I trial involving 9 patients with advanced squamous cell lung cancer tested the combination of nedaplatin and S-1, establishing a maximum tolerated dose of 80 mg/m2 for nedaplatin, with dose-limiting toxicities observed in 2 patients.

The recommended dose for further studies was set at 70 mg/m2 for nedaplatin, indicating a need to balance efficacy with safety in this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of nedaplatin and S-1 in patients with advanced squamous cell lung cancer. Kanaji, N., Ishii, T., Ueda, Y., et al.[2020]

This phase II trial aims to evaluate the safety and efficacy of nedaplatin combined with chemoradiotherapy for treating locally advanced cervical cancer in Japanese patients, specifically targeting those with certain stages of the disease and bulky tumors.

The study will assess the primary endpoint of 3-year overall survival and secondary outcomes including tumor response and adverse events, with a goal of recruiting 45 patients over 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501). Niibe, Y., Hayakawa, K., Tsunoda, S., et al.[2018]

Nedaplatin (254-S), a cisplatin analog, was tested in combination with 5-FU for treating head and neck squamous cell carcinoma (HNSCC) in 36 patients, resulting in a response rate of 37.1% and a complete response (CR) rate of 8.6%.

The efficacy of the 254-S and 5-FU combination was found to be inferior to the previously used four-drug regimen (CDDP, 5-FU, MTX, and LV), which had a response rate of 87% and a CR rate of 33%, indicating the need for further research to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of combination chemotherapy with nedaplatin and 5-FU for head and neck squamous cell carcinoma]. Yamaoka, H., Tsukuda, M., Enomoto, H., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase I-II study of irinotecan (CPT-11) plus nedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrent cervical cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Phase I trial of nedaplatin and S-1 in patients with advanced squamous cell lung cancer. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Phase II study of radiation therapy combined with weekly nedaplatin in locally advanced uterine cervical carcinoma: Kitasato Gynecologic Radiation Oncology Group (KGROG 0501). [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

[Effect of combination chemotherapy with nedaplatin and 5-FU for head and neck squamous cell carcinoma]. [2013]

5. Japan pubmed.ncbi.nlm.nih.gov

[Combined irinotecan (CPT-11) and nedaplatin (254-S) therapy for advanced and/or recurrent cervical cancer]. [2018]