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

NCT02025556 | Completed Phase 2 Results

• 1 other identifier: LBR-101-022
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 63

Brief 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

Keywords

High Frequency Episodic Migraine Headache; Episodic Migraine Headache; Migraine Headache

Outcome Measures

Primary Outcomes (3)

• Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12

  A migraine day was endorsed when at least 1 of the following situations occurred: 1) A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine, or 2) a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only one migraine criterion is missing, or 3) the participant used acute migraine medication (triptans and ergot compounds) to treat a headache of any duration, or 4) any of the above days preceded or followed by a day with a headache of any duration. This calculation was defined as the change from baseline in the number of headache days 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

• Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs)

  Adverse events were rated based on the investigator's clinical judgment. Mild: awareness of a sign or symptom that was easily tolerated Moderate: sign or symptom intense enough to interfere with usual activity Severe: interfered significantly with ability to do work or usual activity

  Up to week 12

Secondary Outcomes (1)

• Change From Baseline in Number of Days With Headache of Any Severity

  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 High Dose LBR-101 Monthly x 3

Also known as: Fremanezumab

LBR-101 High Dose

LBR-101 Low Dose DRUG

Subcutaneously Administered Low Dose 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.
• Subjects fulfilling criteria for episodic migraine as per the Second Edition of The International Headache Society (Olesen and Steiner 2004), who experience migraine at high frequency as follows:
• i. History of headaches on more than 8 days per month for at least 3 months prior to screening
• ii. Verification of headache frequency through prospectively collected baseline information during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days with at total of 8 to 14 days\* fulfilling criteria for migraine.
• \*Operational definition for migraine and probable migraine days are presented in the statistical section of this protocol.
• 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 by entry of headache data on a minimum of 22/28 days (80% compliance).

You may not qualify if:

• 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 six months prior to screening.
• Subject uses 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
• NCGS, Inc.: collaborator

Study Sites (63)

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 158

Little Rock, Arkansas, 72205, 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 159

Hollywood, Florida, 33024, 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 160

South Miami, Florida, 33143, 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 165

Raleigh, North Carolina, 27612, 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 156

Mansfield, Texas, 76063, United States

Location

Teva Investigational Site 157

Salt Lake City, Utah, 84107, 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 (5)

• Silberstein SD, Rapoport AM, Loupe PS, Aycardi E, McDonald M, Yang R, Bigal ME. The Effect of Beginning Treatment With Fremanezumab on Headache and Associated Symptoms in the Randomized Phase 2 Study of High Frequency Episodic Migraine: Post-Hoc Analyses on the First 3 Weeks of Treatment. Headache. 2019 Mar;59(3):383-393. doi: 10.1111/head.13446. Epub 2018 Nov 18.

  PMID: 30450545 DERIVED

• 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, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R, Loupe PS, Burstein R, Newman LC, Lipton RB. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015 Nov;14(11):1081-90. doi: 10.1016/S1474-4422(15)00249-5. Epub 2015 Sep 30.

  PMID: 26432182 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

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 Pharmaceuticals USA

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 1, 2014
• Study Start: January 31, 2014
• Primary Completion: January 31, 2015
• Study Completion: March 31, 2015
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-01

Locations

US (63)