Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
NCT ID: NCT03303092
Last Updated: 2021-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
357 participants
INTERVENTIONAL
2017-12-19
2019-11-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TEV-48125 (225/225/225 mg) group
TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).
TEV-48125
TEV-48125 will be subcutaneously administered once monthly for 3 months.
TEV-48125 (675 mg/placebo/placebo) group
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).
TEV-48125 or placebo
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
Placebo group
Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).
Placebo
Placebo will be subcutaneously administered once monthly for 3 months.
Interventions
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TEV-48125
TEV-48125 will be subcutaneously administered once monthly for 3 months.
TEV-48125 or placebo
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
Placebo
Placebo will be subcutaneously administered once monthly for 3 months.
Eligibility Criteria
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Inclusion Criteria
* Patient fulfills the criteria for Episodic migraine in baseline information collected during the 28 day screening period
* Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.
Exclusion Criteria
\- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
18 Years
70 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Takehisa Matsumaru
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Saitama Medical University Hospital
Iruma, , Japan
Countries
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References
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Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X, Koga N. Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain. 2022 Feb 9;23(1):24. doi: 10.1186/s10194-022-01393-0.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-173725
Identifier Type: OTHER
Identifier Source: secondary_id
406-102-00002
Identifier Type: -
Identifier Source: org_study_id
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