A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
NCT ID: NCT04355117
Last Updated: 2021-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2020-06-17
2020-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment: TEV-48125
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Interventions
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Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Eligibility Criteria
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Inclusion Criteria
* Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period
Exclusion Criteria
* Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:
* Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
* Less than 1 year has passed since the final administration of TEV-48125
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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Sendai Zutsu No-Shinkei Clinic
Sendai, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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406-102-00005
Identifier Type: -
Identifier Source: org_study_id