Back to resultsAssessment of LBR-101 In Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LBR-101 High Dose
LBR-101 Low Dose
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine focused on measuring Headache, Migraine, Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Teva Investigational Site 145
- Teva Investigational Site 130
- Teva Investigational Site 117
- Teva Investigational Site 161
- Teva Investigational Site 116
- Teva Investigational Site 119
- Teva Investigational Site 146
- Teva Investigational Site 113
- Teva Investigational Site 108
- Teva Investigational Site 112
- Teva Investigational Site 132
- Teva Investigational Site 162
- Teva Investigational Site 143
- Teva Investigational Site 137
- Teva Investigational Site 101
- Teva Investigational Site 166
- Teva Investigational Site 129
- Teva Investigational Site 167
- Teva Investigational Site 139
- Teva Investigational Site 140
- Teva Investigational Site 149
- Teva Investigational Site 164
- Teva Investigational Site 134
- Teva Investigational Site 125
- Teva Investigational Site 133
- Teva Investigational Site 135
- Teva Investigational Site 124
- Teva Investigational Site 151
- Teva Investigational Site 109
- Teva Investigational Site 115
- Teva Investigational Site 110
- Teva Investigational Site 114
- Teva Investigational Site 150
- Teva Investigational Site 152
- Teva Investigational Site 104
- Teva Investigational Site 107
- Teva Investigational Site 148
- Teva Investigational Site 105
- Teva Investigational Site 131
- Teva Investigational Site 118
- Teva Investigational Site 168
- Teva Investigational Site 122
- Teva Investigational Site 141
- Teva Investigational Site 142
- Teva Investigational Site 155
- Teva Investigational Site 102
- Teva Investigational Site 127
- Teva Investigational Site 111
- Teva Investigational Site 120
- Teva Investigational Site 153
- Teva Investigational Site 126
- Teva Investigational Site 154
- Teva Investigational Site 128
- Teva Investigational Site 121
- Teva Investigational Site 136
- Teva Investigational Site 123
- Teva Investigational Site 144
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LBR-101 High Dose
LBR-101 Low Dose
Placebo
Arm Description
Subcutaneous High Dose LBR-101 Administered Monthly x 3
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
Subcutaneous Placebo Administered Monthly x 3
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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 headache days of at least moderate 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.
Full Information
NCT ID
NCT02021773
First Posted
December 20, 2013
Last Updated
December 7, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02021773
Brief Title
Assessment of LBR-101 In Chronic Migraine
Official Title
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
February 28, 2015 (Actual)
Study Completion Date
March 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be compared to placebo for safety and efficacy. The mean change from baseline in the number of cumulative headache hours measured at the 28-day period ending with week 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
Headache, Migraine, Chronic Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBR-101 High Dose
Arm Type
Experimental
Arm Description
Subcutaneous High Dose LBR-101 Administered Monthly x 3
Arm Title
LBR-101 Low Dose
Arm Type
Experimental
Arm Description
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous Placebo Administered Monthly x 3
Intervention Type
Drug
Intervention Name(s)
LBR-101 High Dose
Other Intervention Name(s)
Fremanezumab
Intervention Description
Subcutaneously Administered LBR-101 Monthly x 3
Intervention Type
Drug
Intervention Name(s)
LBR-101 Low Dose
Other Intervention Name(s)
Fremanezumab
Intervention Description
Subcutaneously Administered LBR-101 Monthly x 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to week 12
Title
Number of Participants With at Least One Adverse Event
Description
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.
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
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
Description
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 headache days of at least moderate 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.
Time Frame
Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 145
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Teva Investigational Site 130
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Teva Investigational Site 117
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Teva Investigational Site 161
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Teva Investigational Site 116
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Teva Investigational Site 119
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Teva Investigational Site 146
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Teva Investigational Site 113
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Teva Investigational Site 108
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Teva Investigational Site 112
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Teva Investigational Site 132
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Teva Investigational Site 162
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Teva Investigational Site 143
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Teva Investigational Site 137
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Teva Investigational Site 101
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Teva Investigational Site 166
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Teva Investigational Site 129
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Teva Investigational Site 167
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Teva Investigational Site 139
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Teva Investigational Site 140
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Teva Investigational Site 149
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Teva Investigational Site 164
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Teva Investigational Site 134
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Teva Investigational Site 125
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Teva Investigational Site 133
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Teva Investigational Site 135
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Teva Investigational Site 124
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Teva Investigational Site 151
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Teva Investigational Site 109
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Teva Investigational Site 115
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Teva Investigational Site 110
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Teva Investigational Site 114
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Teva Investigational Site 150
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Teva Investigational Site 152
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Teva Investigational Site 104
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Teva Investigational Site 107
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Teva Investigational Site 148
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Teva Investigational Site 105
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Teva Investigational Site 131
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405-6962
Country
United States
Facility Name
Teva Investigational Site 118
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Teva Investigational Site 168
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Teva Investigational Site 122
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Teva Investigational Site 141
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Teva Investigational Site 142
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Teva Investigational Site 155
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Teva Investigational Site 102
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Teva Investigational Site 127
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Teva Investigational Site 111
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Teva Investigational Site 120
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Teva Investigational Site 153
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Teva Investigational Site 126
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Teva Investigational Site 154
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Teva Investigational Site 128
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Teva Investigational Site 121
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Teva Investigational Site 136
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Teva Investigational Site 123
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Teva Investigational Site 144
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30120138
Citation
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.
Results Reference
derived
PubMed Identifier
29722276
Citation
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.
Results Reference
derived
PubMed Identifier
28862758
Citation
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.
Results Reference
derived
PubMed Identifier
26432181
Citation
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.
Results Reference
derived
Learn more about this trial
Assessment of LBR-101 In Chronic Migraine
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