CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,130 enrolled
Drug / intervention
Fremanezumab +1 moredrug
Likely dose
Fremanezumab 225 mgfrom 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/NCT02621931
NCT02621931Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Dec 4, 2015·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Fremanezumab and Placebo for Migraine. Completed, enrolled 1,130 participants across 273 sites in 9 countries.

Detailed Summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

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 4, 2015
Enrollment StartMar 22, 2016
Primary CompletionApr 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.6 years ago

Interventions

Fremanezumabdrug

Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.

Placebodrug

Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.