At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,890 enrolled

Drug / intervention

Fremanezumab +1 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/NCT02638103

NCT02638103Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Dec 22, 2015·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Fremanezumab and Placebo for Migraine. Completed, enrolled 1,890 participants across 139 sites in 9 countries.

Detailed Summary

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMigraine

CountriesCanada, Czechia, Finland, Israel, Japan, Poland, Russia, Spain, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedDec 2015

Enrollment StartFeb 2016

Primary CompletionJun 2018

Study CompletionDec 2018

TodayJul 2026

First PostedDec 22, 2015

Enrollment StartFeb 26, 2016

Primary CompletionJun 6, 2018

Study CompletionDec 8, 2018

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 10.5 years ago

Interventions

Fremanezumabdrug

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Placebodrug

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.