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A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine

NCT02025556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2022-01-24

Study results available
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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.

Conditions

  • Episodic Migraine Headache

Interventions

DRUG

LBR-101 High Dose

Subcutaneously Administered High Dose LBR-101 Monthly x 3

DRUG

LBR-101 Low Dose

Subcutaneously Administered Low Dose LBR-101 Monthly x 3

DRUG

Placebo

Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Sponsors & Collaborators

  • NCGS, Inc.

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Pharmaceuticals USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025556 on ClinicalTrials.gov