A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
Status: | Completed |
---|---|
Conditions: | Migraine Headaches, Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/17/2018 |
Start Date: | January 2014 |
End Date: | March 2015 |
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 is safe and provides migraine prevention in subjects with high frequency episodic
migraine.
LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic
migraine.
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.
- 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 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.
We found this trial at
59
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