Assessment of LBR-101 In Chronic Migraine
Status: | Completed |
---|---|
Conditions: | 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, 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
The purpose of the study is to determine whether monthly subcutaneous administration of
LBR-101 is safe and provides migraine prevention in patients with chronic migraine.
LBR-101 is safe and provides migraine prevention in patients with chronic migraine.
Two distinct doses of subcutaneous LBR-101 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.
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.
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.
We found this trial at
53
sites
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