CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 571 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.

Search/NCT03303079
NCT03303079Phase 3Completed
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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 Chronic Migraine

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 5, 2017·Updated Jun 15, 2021

In Brief

A Phase 3 clinical trial evaluating TEV-48125, TEV-48125 or placebo, and 1 other intervention for Migraine. Completed, enrolled 571 participants across 1 site.

Detailed Summary

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compared with placebo for preventive treatment in Chronic Migraine patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 5, 2017
Enrollment StartDec 19, 2017
Primary CompletionNov 30, 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.