Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase-II Trial: AdrenoMedullin for Ischemic Stroke Study
•A clinical trial of adrenomedullin for ischemic stroke (AMFIS) is being planned.•The AMFIS study is a randomized, double-blind, placebo-controlled phase II trial.•Adrenomedullin is a highly conserved vasoactive peptide with angiogenic properties.•Adrenomedullin is expected to be a novel treatment f...
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| Published in: | Journal of stroke and cerebrovascular diseases Vol. 30; no. 6; p. 105761 |
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| Main Authors: | , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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01-06-2021
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| Abstract | •A clinical trial of adrenomedullin for ischemic stroke (AMFIS) is being planned.•The AMFIS study is a randomized, double-blind, placebo-controlled phase II trial.•Adrenomedullin is a highly conserved vasoactive peptide with angiogenic properties.•Adrenomedullin is expected to be a novel treatment for acute ischemic stroke.
Adrenomedullin (AM), a vasoactive peptide, has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models. After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed. The current AdrenoMedullin For Ischemic Stroke (AMFIS) study aims to assess the safety and efficacy of AM in patients with acute ischemic stroke.
The AMFIS study is an investigator-initiated, randomized, double-blind, phase-II trial. AM or placebo will be administered to patients with non-cardioembolic ischemic stroke within 24 h after stroke onset. In the first cohort of the AMFIS study, patients will be randomly allocated to the investigation treatment A (30 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). In the second cohort, patients will be assigned to the investigation treatment B (56 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10).
Serious adverse events related to the protocol treatment will be evaluated as the primary outcome. All adverse events will be analyzed as the secondary outcome. Regarding efficacy endpoints, the change in National Institutes of Health Stroke Scale and modified Rankin Scale scores will be compared between investigation treatment and placebo groups.
AM is expected to be a safe and effective treatment for ischemic stroke. |
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| AbstractList | Adrenomedullin (AM), a vasoactive peptide, has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models. After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed. The current AdrenoMedullin For Ischemic Stroke (AMFIS) study aims to assess the safety and efficacy of AM in patients with acute ischemic stroke.
The AMFIS study is an investigator-initiated, randomized, double-blind, phase-II trial. AM or placebo will be administered to patients with non-cardioembolic ischemic stroke within 24 h after stroke onset. In the first cohort of the AMFIS study, patients will be randomly allocated to the investigation treatment A (30 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). In the second cohort, patients will be assigned to the investigation treatment B (56 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10).
Serious adverse events related to the protocol treatment will be evaluated as the primary outcome. All adverse events will be analyzed as the secondary outcome. Regarding efficacy endpoints, the change in National Institutes of Health Stroke Scale and modified Rankin Scale scores will be compared between investigation treatment and placebo groups.
AM is expected to be a safe and effective treatment for ischemic stroke. •A clinical trial of adrenomedullin for ischemic stroke (AMFIS) is being planned.•The AMFIS study is a randomized, double-blind, placebo-controlled phase II trial.•Adrenomedullin is a highly conserved vasoactive peptide with angiogenic properties.•Adrenomedullin is expected to be a novel treatment for acute ischemic stroke. Adrenomedullin (AM), a vasoactive peptide, has strong anti-inflammatory and angiogenic properties, which have been reported to ameliorate the consequences of ischemic stroke in several animal models. After a phase I study in healthy volunteers, two phase II trials of AM for inflammatory bowel diseases have been recently completed. The current AdrenoMedullin For Ischemic Stroke (AMFIS) study aims to assess the safety and efficacy of AM in patients with acute ischemic stroke. The AMFIS study is an investigator-initiated, randomized, double-blind, phase-II trial. AM or placebo will be administered to patients with non-cardioembolic ischemic stroke within 24 h after stroke onset. In the first cohort of the AMFIS study, patients will be randomly allocated to the investigation treatment A (30 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). In the second cohort, patients will be assigned to the investigation treatment B (56 μg/kg of AM in total for 7 days, n = 20) or placebo group (n = 10). Serious adverse events related to the protocol treatment will be evaluated as the primary outcome. All adverse events will be analyzed as the secondary outcome. Regarding efficacy endpoints, the change in National Institutes of Health Stroke Scale and modified Rankin Scale scores will be compared between investigation treatment and placebo groups. AM is expected to be a safe and effective treatment for ischemic stroke. |
| ArticleNumber | 105761 |
| Author | Hattori, Yorito Maruyama, Hirofumi Omae, Katsuhiro Fukuma, Kazuki Kita, Toshihiro Yoshimoto, Takeshi Kakuta, Ryosuke Kitamura, Kazuo Ihara, Masafumi Saito, Satoshi Yamamoto, Haruko |
| Author_xml | – sequence: 1 givenname: Takeshi orcidid: 0000-0003-3178-8171 surname: Yoshimoto fullname: Yoshimoto, Takeshi email: yoshimototakeshi1982@ncvc.go.jp organization: Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan – sequence: 2 givenname: Satoshi surname: Saito fullname: Saito, Satoshi email: saitou.satoshi.43m@kyoto-u.jp organization: Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan – sequence: 3 givenname: Katsuhiro surname: Omae fullname: Omae, Katsuhiro email: k.omae@ncvc.go.jp organization: Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan – sequence: 4 givenname: Yorito surname: Hattori fullname: Hattori, Yorito email: yoh2019@ncvc.go.jp organization: Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan – sequence: 5 givenname: Kazuki surname: Fukuma fullname: Fukuma, Kazuki email: kazblues77@ncvc.go.jp organization: Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan – sequence: 6 givenname: Kazuo surname: Kitamura fullname: Kitamura, Kazuo email: kazuokit@med.miyazaki-u.ac.jp organization: Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan – sequence: 7 givenname: Ryosuke surname: Kakuta fullname: Kakuta, Ryosuke email: r_kakuta@ncvc.go.jp organization: Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan – sequence: 8 givenname: Toshihiro surname: Kita fullname: Kita, Toshihiro email: toshihiro_kita@med.miyazaki-u.ac.jp organization: Division of Circulatory and Body Fluid Regulation, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan – sequence: 9 givenname: Hirofumi orcidid: 0000-0001-7613-8717 surname: Maruyama fullname: Maruyama, Hirofumi email: hmaru@hiroshima-u.ac.jp organization: Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan – sequence: 10 givenname: Haruko surname: Yamamoto fullname: Yamamoto, Haruko email: harukoya@ncvc.go.jp organization: Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan – sequence: 11 givenname: Masafumi orcidid: 0000-0002-7102-4048 surname: Ihara fullname: Ihara, Masafumi email: ihara@ncvc.go.jp organization: Department of Neurology, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33813084$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1038_s41440_021_00806_y crossref_primary_10_1016_j_neuint_2021_105015 crossref_primary_10_1016_j_jstrokecerebrovasdis_2022_106695 crossref_primary_10_1161_CIRCRESAHA_123_321673 |
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| Issue | 6 |
| Keywords | Adrenomedullin Clinical trial Protocols Treatment Ischemic stroke Peptide |
| Language | English |
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