New shot cuts migraine days by half in chinese trial
NCT ID NCT05458011
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called fremanezumab, given as a shot under the skin, to prevent migraines in 365 Chinese adults. Participants received either monthly or quarterly injections or a placebo for 12 weeks, followed by an open-label period. The main goal was to see if the drug reduced the number of migraine days per month. The trial was completed and showed that fremanezumab helped lower migraine frequency.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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365 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participant has a diagnosis of migraine with onset at ≤50 years of age. * The participant has a body weight ≥45 kg and body mass index within the range 17.5 to 34.9 kg/m2 (inclusive). * The participant has a history of migraine for ≥12 months prior to screening. * Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and for 6.0 months after discontinuation of investigational medicinal product (IMP). * Men must be sterile or, if they are potentially fertile/reproductively competent (not congenitally sterile) and their female partners are of childbearing potential, should use highly effective birth control for the duration of the study. * Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: * Use of medications containing opioids (including codeine), barbiturates (including butalbital), or any combination product containing opioids or barbiturates (including butalbital) on more than 4 days during the screening period for the treatment of migraine or for any other reason. * Has used an intervention/device (eg, scheduled nerve blocks or transcranial magnetic stimulation) for migraine, or in the head or neck area, during the 2 months prior to screening (visit 1). * History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], or peripheral extremity ischemia or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism. * History of human immunodeficiency virus, tuberculosis, Lyme disease, or a known or suspected active infection of coronavirus disease 2019 (COVID-19). * Known current infection or history of infection in the past 6 months with hepatitis B or C viruses. * History of cancer in the past 5 years, except for appropriately treated non-melanoma skin carcinoma. * History of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs), or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or is concomitantly using lamotrigine. * Any clinically significant uncontrolled medical condition (treated or untreated). * History of alcohol or drug abuse during the past 2 years or drug dependence during the past 5 years. * Additional criteria apply, please contact the investigator for more information.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Teva Investigational Site 88001
Beijing, 100853, China
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Teva Investigational Site 88003
Chengdu, 610041, China
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Teva Investigational Site 88004
Beijing, 100044, China
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Teva Investigational Site 88005
Luoyang, 4710039, China
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Teva Investigational Site 88006
Wuhan, 430071, China
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Teva Investigational Site 88008
Changchun, 130021, China
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Teva Investigational Site 88009
Changchun, 130041, China
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Teva Investigational Site 88010
Lianyungang, 222002, China
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Teva Investigational Site 88011
Shijiazhuang, 50073, China
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Teva Investigational Site 88012
Wuhan, 430030, China
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Teva Investigational Site 88013
Guiyang, 550004, China
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Teva Investigational Site 88015
Suzhou, 215004, China
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Teva Investigational Site 88016
Shenyang, 110016, China
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Teva Investigational Site 88017
Wenzhou, 325000, China
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Teva Investigational Site 88019
Fuzhou, 350001, China
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Teva Investigational Site 88020
Guangzhou, 510260, China
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Teva Investigational Site 88021
Shanghaishi, 200040, China
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Teva Investigational Site 88022
Changsha Shi, 410008, China
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Teva Investigational Site 88023
Tianjin, 300120, China
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Teva Investigational Site 88024
Tianjin, 300052, China
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Teva Investigational Site 88025
Shanghaishi, 200120, China
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Teva Investigational Site 88026
Harbin, 150001, China
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Teva Investigational Site 88028
Baotou Shi, 014060, China
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Teva Investigational Site 88029
Chongqing, 400700, China
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Teva Investigational Site 88030
Changsha Shi, 410013, China
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Teva Investigational Site 88031
Zhanjiang, 524008, China
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Teva Investigational Site 88032
Xining, 810007, China
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Teva Investigational Site 88033
Rizhao, 276800, China
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Teva Investigational Site 88034
Zhengzhou, 450003, China
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