Assessment of LBR-101 In Chronic Migraine

NCT02021773 | Completed Phase 2 Results

• 1 other identifier: LBR-101-021
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 57

Brief Summary

The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic migraine.

Conditions

Chronic Migraine

Keywords

Headache; Migraine; Chronic Migraine

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in the Number of Monthly Cumulative Headache Hours of Any Severity on Headache Days Relative to the 28-day Post-treatment Period Ending With Week 12

  A headache day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache of any severity or the participant used acute migraine medication (triptans and ergot compounds) to treat a headache. This calculation was defined as the change from baseline in the number of hours with headache of any severity during the 28-day post treatment period ending at week 12. Headache severity was rated daily by the participant as either no pain, mild, moderate, or severe.

  Baseline to week 12

• Number of Participants With at Least One Adverse Event

  An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline to week 12

Secondary Outcomes (1)

• Mean Change From Baseline in the Number of Headache Days of at Least Moderate Severity Relative to the 28-day Post-treatment Period Ending With Week 12

  Baseline to week 12

Study Arms (3)

LBR-101 High Dose

EXPERIMENTAL

Subcutaneous High Dose LBR-101 Administered Monthly x 3

Drug: LBR-101 High Dose

LBR-101 Low Dose

EXPERIMENTAL

Subcutaneous Low Dose LBR-101 Administered Monthly x 3

Drug: LBR-101 Low Dose

Placebo

PLACEBO COMPARATOR

Subcutaneous Placebo Administered Monthly x 3

Drug: Placebo

Interventions

LBR-101 High Dose DRUG

Subcutaneously Administered LBR-101 Monthly x 3

Also known as: Fremanezumab

LBR-101 High Dose

LBR-101 Low Dose DRUG

Subcutaneously Administered LBR-101 Monthly x 3

Also known as: Fremanezumab

LBR-101 Low Dose

Placebo DRUG

Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 to 65 years of age.
• A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
• Chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013)
• Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg inclusive.
• Demonstrated compliance with the electronic headache diary during the run-in period headache data on a minimum of 22/28 days (80% diary compliance)

You may not qualify if:

• Onset of chronic migraine after the age of 50 years.
• Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 6 months prior to study entry.
• Subject is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
• Failed \> 2 medication categories or \> 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
• Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (57)

Teva Investigational Site 145

Gilbert, Arizona, 85234, United States

Location

Teva Investigational Site 130

Phoenix, Arizona, 85032, United States

Location

Teva Investigational Site 117

Scottsdale, Arizona, 85259, United States

Location

Teva Investigational Site 161

Anaheim, California, 92801, United States

Location

Teva Investigational Site 116

Fullerton, California, 92835, United States

Location

Teva Investigational Site 119

Long Beach, California, 90806, United States

Location

Teva Investigational Site 146

Oceanside, California, 92056, United States

Location

Teva Investigational Site 113

San Francisco, California, 94109, United States

Location

Teva Investigational Site 108

Stanford, California, 94305, United States

Location

Teva Investigational Site 112

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 132

Boulder, Colorado, 80304, United States

Location

Teva Investigational Site 162

Stamford, Connecticut, 06905, United States

Location

Teva Investigational Site 143

DeLand, Florida, 32720, United States

Location

Teva Investigational Site 137

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 101

Jacksonville, Florida, 32216, United States

Location

Teva Investigational Site 166

Jacksonville, Florida, 32256, United States

Location

Teva Investigational Site 129

Maitland, Florida, 32751, United States

Location

Teva Investigational Site 167

Orlando, Florida, 32801, United States

Location

Teva Investigational Site 139

Ormond Beach, Florida, 32174, United States

Location

Teva Investigational Site 140

Port Orange, Florida, 32127, United States

Location

Teva Investigational Site 149

Atlanta, Georgia, 30342, United States

Location

Teva Investigational Site 164

Decatur, Georgia, 30030, United States

Location

Teva Investigational Site 134

Douglasville, Georgia, 30134, United States

Location

Teva Investigational Site 125

Evansville, Indiana, 47714, United States

Location

Teva Investigational Site 133

Lenexa, Kansas, 66214, United States

Location

Teva Investigational Site 135

Brockton, Massachusetts, 02301, United States

Location

Teva Investigational Site 124

New Bedford, Massachusetts, 02740, United States

Location

Teva Investigational Site 151

Springfield, Massachusetts, 01104, United States

Location

Teva Investigational Site 109

Watertown, Massachusetts, 02472, United States

Location

Teva Investigational Site 115

Worcester, Massachusetts, 01605, United States

Location

Teva Investigational Site 110

Ann Arbor, Michigan, 48104, United States

Location

Teva Investigational Site 114

Kalamazoo, Michigan, 49009, United States

Location

Teva Investigational Site 150

Golden Valley, Minnesota, 55422, United States

Location

Teva Investigational Site 152

Kansas City, Missouri, 64114, United States

Location

Teva Investigational Site 107

Springfield, Missouri, 65807, United States

Location

Teva Investigational Site 104

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 148

Reno, Nevada, 89502, United States

Location

Teva Investigational Site 105

The Bronx, New York, 10461, United States

Location

Teva Investigational Site 131

Greensboro, North Carolina, 27405-6962, United States

Location

Teva Investigational Site 118

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 168

Winston-Salem, North Carolina, 27103, United States

Location

Teva Investigational Site 122

Canton, Ohio, 44718, United States

Location

Teva Investigational Site 141

Cincinnati, Ohio, 45227, United States

Location

Teva Investigational Site 142

Cincinnati, Ohio, 45229-3039, United States

Location

Teva Investigational Site 155

Cleveland, Ohio, 44195, United States

Location

Teva Investigational Site 102

Columbus, Ohio, 43221, United States

Location

Teva Investigational Site 127

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 111

Philadelphia, Pennsylvania, 19107, United States

Location

Teva Investigational Site 120

Goose Creek, South Carolina, 29445, United States

Location

Teva Investigational Site 153

Bristol, Tennessee, 37620, United States

Location

Teva Investigational Site 126

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 154

Nashville, Tennessee, 37203, United States

Location

Teva Investigational Site 128

Arlington, Texas, 76012, United States

Location

Teva Investigational Site 121

Austin, Texas, 78731, United States

Location

Teva Investigational Site 136

Austin, Texas, 78745, United States

Location

Teva Investigational Site 123

Charlottesville, Virginia, 22911, United States

Location

Teva Investigational Site 144

Roanoke, Virginia, 24018, United States

Location

Related Publications (4)

• VanderPluym J, Dodick DW, Lipton RB, Ma Y, Loupe PS, Bigal ME. Fremanezumab for preventive treatment of migraine: Functional status on headache-free days. Neurology. 2018 Sep 18;91(12):e1152-e1165. doi: 10.1212/01.wnl.0000544321.19316.40. Epub 2018 Aug 17.

  PMID: 30120138 DERIVED

• Halker Singh RB, Aycardi E, Bigal ME, Loupe PS, McDonald M, Dodick DW. Sustained reductions in migraine days, moderate-to-severe headache days and days with acute medication use for HFEM and CM patients taking fremanezumab: Post-hoc analyses from phase 2 trials. Cephalalgia. 2019 Jan;39(1):52-60. doi: 10.1177/0333102418772585. Epub 2018 May 3.

  PMID: 29722276 DERIVED

• Cohen JM, Dodick DW, Yang R, Newman LC, Li T, Aycardi E, Bigal ME. Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. Headache. 2017 Oct;57(9):1375-1384. doi: 10.1111/head.13156. Epub 2017 Sep 1.

  PMID: 28862758 DERIVED

• Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R, Silberstein SD. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015 Nov;14(11):1091-100. doi: 10.1016/S1474-4422(15)00245-8. Epub 2015 Sep 30.

  PMID: 26432181 DERIVED

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: January 31, 2014
• Primary Completion: February 28, 2015
• Study Completion: March 31, 2015
• Last Updated: December 9, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-12

Locations

US (57)