A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
NCT ID: NCT02025556
Last Updated: 2022-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
297 participants
INTERVENTIONAL
2014-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LBR-101 High Dose
Subcutaneous High Dose LBR-101 Administered Monthly x 3
LBR-101 High Dose
Subcutaneously Administered High Dose LBR-101 Monthly x 3
LBR-101 Low Dose
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
LBR-101 Low Dose
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Placebo
Subcutaneous Placebo Administered Monthly x 3
Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Interventions
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LBR-101 High Dose
Subcutaneously Administered High Dose LBR-101 Monthly x 3
LBR-101 Low Dose
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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NCGS, Inc.
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Pharmaceuticals USA
Locations
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Teva Investigational Site 145
Gilbert, Arizona, United States
Teva Investigational Site 130
Phoenix, Arizona, United States
Teva Investigational Site 117
Scottsdale, Arizona, United States
Teva Investigational Site 158
Little Rock, Arkansas, United States
Teva Investigational Site 161
Anaheim, California, United States
Teva Investigational Site 116
Fullerton, California, United States
Teva Investigational Site 119
Long Beach, California, United States
Teva Investigational Site 146
Oceanside, California, United States
Teva Investigational Site 113
San Francisco, California, United States
Teva Investigational Site 108
Stanford, California, United States
Teva Investigational Site 112
Walnut Creek, California, United States
Teva Investigational Site 132
Boulder, Colorado, United States
Teva Investigational Site 162
Stamford, Connecticut, United States
Teva Investigational Site 143
DeLand, Florida, United States
Teva Investigational Site 137
Hialeah, Florida, United States
Teva Investigational Site 159
Hollywood, Florida, United States
Teva Investigational Site 101
Jacksonville, Florida, United States
Teva Investigational Site 166
Jacksonville, Florida, United States
Teva Investigational Site 129
Maitland, Florida, United States
Teva Investigational Site 167
Orlando, Florida, United States
Teva Investigational Site 139
Ormond Beach, Florida, United States
Teva Investigational Site 140
Port Orange, Florida, United States
Teva Investigational Site 160
South Miami, Florida, United States
Teva Investigational Site 149
Atlanta, Georgia, United States
Teva Investigational Site 164
Decatur, Georgia, United States
Teva Investigational Site 134
Douglasville, Georgia, United States
Teva Investigational Site 125
Evansville, Indiana, United States
Teva Investigational Site 133
Lenexa, Kansas, United States
Teva Investigational Site 135
Brockton, Massachusetts, United States
Teva Investigational Site 124
New Bedford, Massachusetts, United States
Teva Investigational Site 151
Springfield, Massachusetts, United States
Teva Investigational Site 109
Watertown, Massachusetts, United States
Teva Investigational Site 115
Worcester, Massachusetts, United States
Teva Investigational Site 110
Ann Arbor, Michigan, United States
Teva Investigational Site 114
Kalamazoo, Michigan, United States
Teva Investigational Site 150
Golden Valley, Minnesota, United States
Teva Investigational Site 152
Kansas City, Missouri, United States
Teva Investigational Site 107
Springfield, Missouri, United States
Teva Investigational Site 104
St Louis, Missouri, United States
Teva Investigational Site 148
Reno, Nevada, United States
Teva Investigational Site 105
The Bronx, New York, United States
Teva Investigational Site 131
Greensboro, North Carolina, United States
Teva Investigational Site 118
Raleigh, North Carolina, United States
Teva Investigational Site 165
Raleigh, North Carolina, United States
Teva Investigational Site 168
Winston-Salem, North Carolina, United States
Teva Investigational Site 122
Canton, Ohio, United States
Teva Investigational Site 141
Cincinnati, Ohio, United States
Teva Investigational Site 142
Cincinnati, Ohio, United States
Teva Investigational Site 155
Cleveland, Ohio, United States
Teva Investigational Site 102
Columbus, Ohio, United States
Teva Investigational Site 127
Oklahoma City, Oklahoma, United States
Teva Investigational Site 111
Philadelphia, Pennsylvania, United States
Teva Investigational Site 120
Goose Creek, South Carolina, United States
Teva Investigational Site 153
Bristol, Tennessee, United States
Teva Investigational Site 126
Memphis, Tennessee, United States
Teva Investigational Site 154
Nashville, Tennessee, United States
Teva Investigational Site 128
Arlington, Texas, United States
Teva Investigational Site 121
Austin, Texas, United States
Teva Investigational Site 136
Austin, Texas, United States
Teva Investigational Site 156
Mansfield, Texas, United States
Teva Investigational Site 157
Salt Lake City, Utah, United States
Teva Investigational Site 123
Charlottesville, Virginia, United States
Teva Investigational Site 144
Roanoke, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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LBR-101-022
Identifier Type: -
Identifier Source: org_study_id
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