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Episodic Migraine HeadachePhase 2NCT02025556

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

A Phase 2 study testing LBR-101 High Dose and LBR-101 Low Dose in people with Episodic Migraine Headache, run by Teva Branded Pharmaceutical Products R&D, Inc. at 63 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic Migraine Headache
What is being tested?
LBR-101 High Dose and LBR-101 Low Dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
63 sitesUnited States
Study dates
31 Jan 2014to 31 Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • History of headaches on more than 8 days per month for at least 3 months prior to screening
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Teva Investigational Site 161

    Anaheim, California, 92801

  • Teva Investigational Site 110

    Ann Arbor, Michigan, 48104

  • Teva Investigational Site 128

    Arlington, Texas, 76012

  • Teva Investigational Site 149

    Atlanta, Georgia, 30342

  • Teva Investigational Site 121

    Austin, Texas, 78731

  • Teva Investigational Site 136

    Austin, Texas, 78745

  • Teva Investigational Site 132

    Boulder, Colorado, 80304

  • Teva Investigational Site 153

    Bristol, Tennessee, 37620

  • Teva Investigational Site 135

    Brockton, Massachusetts, 02301

  • Teva Investigational Site 122

    Canton, Ohio, 44718

  • Teva Investigational Site 123

    Charlottesville, Virginia, 22911

  • Teva Investigational Site 141

    Cincinnati, Ohio, 45227

  • Teva Investigational Site 142

    Cincinnati, Ohio, 45229-3039

  • Teva Investigational Site 155

    Cleveland, Ohio, 44195

  • Teva Investigational Site 102

    Columbus, Ohio, 43221

  • Teva Investigational Site 164

    Decatur, Georgia, 30030

  • Teva Investigational Site 143

    DeLand, Florida, 32720

  • Teva Investigational Site 134

    Douglasville, Georgia, 30134

  • Teva Investigational Site 125

    Evansville, Indiana, 47714

  • Teva Investigational Site 116

    Fullerton, California, 92835

  • Teva Investigational Site 145

    Gilbert, Arizona, 85234

  • Teva Investigational Site 150

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 120

    Goose Creek, South Carolina, 29445

  • Teva Investigational Site 131

    Greensboro, North Carolina, 27405-6962

  • Teva Investigational Site 137

    Hialeah, Florida, 33012

  • Teva Investigational Site 159

    Hollywood, Florida, 33024

  • Teva Investigational Site 101

    Jacksonville, Florida, 32216

  • Teva Investigational Site 166

    Jacksonville, Florida, 32256

  • Teva Investigational Site 114

    Kalamazoo, Michigan, 49009

  • Teva Investigational Site 152

    Kansas City, Missouri, 64114

  • Teva Investigational Site 133

    Lenexa, Kansas, 66214

  • Teva Investigational Site 158

    Little Rock, Arkansas, 72205

  • Teva Investigational Site 119

    Long Beach, California, 90806

  • Teva Investigational Site 129

    Maitland, Florida, 32751

  • Teva Investigational Site 156

    Mansfield, Texas, 76063

  • Teva Investigational Site 126

    Memphis, Tennessee, 38119

  • Teva Investigational Site 154

    Nashville, Tennessee, 37203

  • Teva Investigational Site 124

    New Bedford, Massachusetts, 02740

  • Teva Investigational Site 146

    Oceanside, California, 92056

  • Teva Investigational Site 127

    Oklahoma City, Oklahoma, 73112

  • Teva Investigational Site 167

    Orlando, Florida, 32801

  • Teva Investigational Site 139

    Ormond Beach, Florida, 32174

  • Teva Investigational Site 111

    Philadelphia, Pennsylvania, 19107

  • Teva Investigational Site 130

    Phoenix, Arizona, 85032

  • Teva Investigational Site 140

    Port Orange, Florida, 32127

  • Teva Investigational Site 118

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 165

    Raleigh, North Carolina, 27612

  • Teva Investigational Site 148

    Reno, Nevada, 89502

  • Teva Investigational Site 144

    Roanoke, Virginia, 24018

  • Teva Investigational Site 157

    Salt Lake City, Utah, 84107

  • Teva Investigational Site 113

    San Francisco, California, 94109

  • Teva Investigational Site 117

    Scottsdale, Arizona, 85259

  • Teva Investigational Site 160

    South Miami, Florida, 33143

  • Teva Investigational Site 151

    Springfield, Massachusetts, 01104

  • Teva Investigational Site 107

    Springfield, Missouri, 65807

  • Teva Investigational Site 104

    St Louis, Missouri, 63141

  • Teva Investigational Site 162

    Stamford, Connecticut, 06905

  • Teva Investigational Site 108

    Stanford, California, 94305

  • Teva Investigational Site 105

    The Bronx, New York, 10461

  • Teva Investigational Site 112

    Walnut Creek, California, 94598

  • Teva Investigational Site 109

    Watertown, Massachusetts, 02472

  • Teva Investigational Site 168

    Winston-Salem, North Carolina, 27103

  • Teva Investigational Site 115

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of High Frequency Episodic Migraine

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.

Being tested
LBR-101 High Dose, LBR-101 Low Dose, Placebo
Keywords
High Frequency Episodic Migraine Headache, Episodic Migraine Headache, Migraine Headache
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBR-101 High DoseDrug

    Also called Fremanezumab

    Subcutaneously Administered High Dose LBR-101 Monthly x 3

  • LBR-101 Low DoseDrug

    Also called Fremanezumab

    Subcutaneously Administered Low Dose LBR-101 Monthly x 3

  • PlaceboDrug

    Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Study groups in NCT02025556
Study groupRoleWhat they receive
LBR-101 High DoseExperimentalSubcutaneous High Dose LBR-101 Administered Monthly x 3
Receives: Drug: LBR-101 High Dose
LBR-101 Low DoseExperimentalSubcutaneous Low Dose LBR-101 Administered Monthly x 3
Receives: Drug: LBR-101 Low Dose
PlaceboPlacebo comparatorSubcutaneous Placebo Administered Monthly x 3
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to week 12

  2. 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.

    Measured: Baseline to week 12

  3. 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

    Measured: Up to week 12

Secondary outcomes (1)

  1. Change From Baseline in Number of Days With Headache of Any Severity

    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 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.

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study start31 Jan 2014
  3. Primary completion31 Jan 2015
  4. Study completion31 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025556
Sponsor's protocol ID
LBR-101-022
Status last verified
Jan 2022
First submitted
20 Dec 2013
Last updated
24 Jan 2022
Data monitoring committee
No

Publications

  • 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.

    PubMed 30450545

  • 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.

    PubMed 30120138

  • 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.

    PubMed 29722276

  • 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.

    PubMed 28862758

  • 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.

    PubMed 26432182

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LBR-101 High Dose and LBR-101 Low Dose in people with Episodic Migraine Headache, run by Teva Branded Pharmaceutical Products R&D, Inc. at 63 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Monthly Migraine Days During the 28-day Post Treatment Period Ending With Week 12 (time frame: Baseline to week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025556, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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