Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
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|ClinicalTrials.gov Identifier: NCT03303105|
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: TEV-48125||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine|
|Actual Study Start Date :||January 4, 2018|
|Actual Primary Completion Date :||June 16, 2020|
|Actual Study Completion Date :||June 16, 2020|
Experimental: TEV-48125 (225 mg/1 month) group
TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly [except for a loading dose of 675 mg in subjects with CM]).
TEV-48125 will be administered subcutaneously once every 4 weeks.
Experimental: TEV-48125 (675 mg/3 month) group
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
TEV-48125 will be administered subcutaneously once every 12 weeks.
- Number of Participants With Adverse Events [ Time Frame: Baseline (Day 0) up to follow-up visit (Day 562) ]
- Number of migraine days [ Time Frame: Baseline, Month 12 ]
- Number of headache days of at least moderate severity [ Time Frame: Baseline, Month 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303105
|Saitama Medical University Hospital|
|Study Director:||Takehisa Matsumaru||Otsuka Pharmaceutical Co., Ltd.|