A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
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|ClinicalTrials.gov Identifier: NCT02025556|
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : January 24, 2022
Last Update Posted : January 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Episodic Migraine Headache||Drug: LBR-101 High Dose Drug: LBR-101 Low Dose Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||297 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 31, 2014|
|Actual Primary Completion Date :||January 31, 2015|
|Actual Study Completion Date :||March 31, 2015|
Experimental: LBR-101 High Dose
Subcutaneous High Dose LBR-101 Administered Monthly x 3
Drug: LBR-101 High Dose
Subcutaneously Administered High Dose LBR-101 Monthly x 3
Other Name: Fremanezumab
Experimental: LBR-101 Low Dose
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
Drug: LBR-101 Low Dose
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Other Name: Fremanezumab
Placebo Comparator: Placebo
Subcutaneous Placebo Administered Monthly x 3
Subcutaneously Administered Placebo (Vehicle) Monthly x 3
- 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 ]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.
- Number of Participants With at Least One Adverse Event [ Time Frame: Baseline to week 12 ]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.
- Number of Participants Reporting Mild, Moderate, and Severe Adverse Events (AEs) [ Time Frame: Up to week 12 ]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
- Change From Baseline in Number of Days With Headache of Any Severity [ Time Frame: Baseline to 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 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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025556
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|
|Responsible Party:||Teva Branded Pharmaceutical Products R&D, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 1, 2014 Key Record Dates|
|Results First Posted:||January 24, 2022|
|Last Update Posted:||January 24, 2022|
|Last Verified:||January 2022|
High Frequency Episodic Migraine Headache
Episodic Migraine Headache
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs