At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 357 enrolled
Drug / intervention
TEV-48125 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
In Brief
A Phase 3 clinical trial evaluating TEV-48125, TEV-48125 or placebo, and 1 other intervention for Migraine. Completed, enrolled 357 participants across 1 site.
Detailed Summary
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartDec 2017
Primary CompletionNov 2019
TodayJul 2026
First PostedOct 5, 2017
Enrollment StartDec 19, 2017
Primary CompletionNov 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.7 years ago
Interventions
TEV-48125drug
TEV-48125 will be subcutaneously administered once monthly for 3 months.
TEV-48125 or placebodrug
TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
Placebodrug
Placebo will be subcutaneously administered once monthly for 3 months.