Redasemtide for Stroke

(Revive Trial)

Recruiting at 231 trial locations

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shionogi

Disqualifiers: Severe consciousness decrease, Recent stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 week

849 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called redasemtide for individuals who have experienced an acute ischemic stroke, a stroke caused by a blood clot in the brain. The trial aims to determine the effectiveness and safety of redasemtide for these patients. Participants are divided into two groups: one for those unable to receive typical stroke treatments like clot-busting drugs or surgery, and another for those who can. Suitable candidates for this trial are those who can begin treatment within 25 hours of their stroke and whose condition remains stable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that redasemtide is being tested for safety in treating sudden strokes. In earlier studies, participants generally tolerated redasemtide well. Common side effects included mild headaches and dizziness. These studies have not directly linked any serious side effects to the treatment.

Redasemtide is still under investigation, so while early results appear promising, researchers continue to learn about its safety. Always consult your doctor if considering joining a trial to understand the possible risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Most treatments for stroke focus on restoring blood flow to the brain or preventing further clotting. But redasemtide works differently by potentially promoting the repair and regeneration of brain tissue. This experimental treatment is administered as an intravenous infusion over a short period of just five days during hospitalization, which is relatively quick compared to other methods. Researchers are excited about redasemtide because it represents a novel approach to stroke recovery, offering hope for improved outcomes and faster recovery for patients.

What evidence suggests that redasemtide might be an effective treatment for stroke?

Research has shown that redasemtide may help treat sudden strokes. Previous studies suggest that redasemtide can improve recovery for stroke patients. In this trial, participants will receive either Redasemtide Dose A, Redasemtide Dose B, or a placebo. The treatment involves administering the drug through an IV drip, which may aid brain healing. Early results indicate that patients who receive redasemtide might recover better than those who do not. Overall, evidence suggests that redasemtide could be an effective option for aiding stroke recovery. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Redasemtide

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).

How Is the Trial Designed?

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)

Published Research Related to This Trial

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]

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]

In a study involving 9 patients with cervical cancer, combination therapy using irinotecan and nedaplatin showed a 40% response rate in patients receiving treatment before surgery and a 75% response rate in those with recurrent disease.

While the treatment was effective, it also led to significant side effects, including grade 3 or 4 adverse events such as leukopenia in 4 patients, indicating the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined irinotecan (CPT-11) and nedaplatin (254-S) therapy for advanced and/or recurrent cervical cancer]. Hiruma, R., Kamide, T., Anzai, N., et al.[2018]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05953480

Study Details | NCT05953480 | A Phase 2b, Randomized, ... The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).

2. shionogi.com shionogi.com/global/en/news/2021/12/20211213.html

SHIONOGI Announces Positive Results from a Phase 2 ... This trial was a phase 2 placebo-controlled, double-blind, randomized, controlled trial in patients with acute ischemic stroke within 4.5 to 24 hours after ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20563793

Clinical Trials The purpose of the study is to determine the effectiveness and safety of redasemtide for the treatment of adult participants with acute ischemic stroke.

4. clinicaltrials.eu clinicaltrials.eu/inn/redasemtide/

Redasemtide – Application in Therapy and Current Clinical ... The main goal of this study is to see if Redasemtide can improve outcomes for stroke patients. ... The main objectives of this trial are to compare the efficacy ...

5. trial.medpath.com trial.medpath.com/clinical-trial/5ca3e2513dd713be/efficacy-safety-redasemtide-stroke

A Phase 2b, Randomized, Double-blind Study of ... - MedPath The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05953480

Study Details | NCT05953480 | A Phase 2b, Randomized, ... The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).

7. trial.medpath.com trial.medpath.com/clinical-trial/1c1206f6c147dea6/jprn-jrct2031230083-redasemtide-efficacy-safety-acute-ischemic-stroke

A phase 2b, randomized, double-blind study of redasemtide ... What are the potential adverse events and safety management strategies for redasemtide (S-005151) in stroke patients? Are there other neuroprotective ...