At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 297 enrolled
Drug / intervention
LBR-101 High Dose +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, Study Comparing the Efficacy and Safety of Two Doses of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of High Frequency Episodic Migraine
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jan 1, 2014·Updated Jan 24, 2022
In Brief
A Phase 2 clinical trial evaluating LBR-101 High Dose, LBR-101 Low Dose, and 1 other intervention for Episodic Migraine Headache. Completed, enrolled 297 participants across 63 sites.
Detailed Summary
The purpose of this study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in subjects with high frequency episodic migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpisodic Migraine Headache
CountriesUnited States
CollaboratorsNCGS, Inc.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartJan 2014
Primary CompletionJan 2015
Study CompletionMar 2015
TodayJul 2026
First PostedJan 1, 2014
Enrollment StartJan 31, 2014
Primary CompletionJan 31, 2015
Study CompletionMar 31, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.5 years ago
Interventions
LBR-101 High Dosedrug
Subcutaneously Administered High Dose LBR-101 Monthly x 3
LBR-101 Low Dosedrug
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Placebodrug
Subcutaneously Administered Placebo (Vehicle) Monthly x 3