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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Labrys Biologics Inc.
Sponsor:
Collaborator:
NCGS, Inc.
Information provided by (Responsible Party):
Labrys Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02025556
First received: December 20, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Episodic Migraine Headache
Biological: LBR-101 High Dose
Biological: LBR-101 Low Dose
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Labrys Biologics Inc.:

Primary Outcome Measures:
  • Efficacy of two distinct doses of subcutaneous LBR-101 in the preventive treatment of HFEM, measured by mean change from baseline in the monthly migraine days during the 28-day post treatment period ending with week 12 [ Time Frame: 12 weeks after first dose of blinded study drug ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability (ie: by measuring the change from baseline in the frequency and severity of adverse events) of LBR-101 in the preventive treatment of HFEM. [ Time Frame: 12 weeks after first dose of blinded study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of two distinct doses of subcutaneous LBR-101 in the preventive treatment of HFEM, measured by mean change from baseline on the number of days with headache of any severity during the 28-day post treatment period ending with week 12 [ Time Frame: 12 weeks after first dose of blinded study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBR-101 High Dose
Subcutaneous High Dose LBR-101 Administered Monthly x 3
Biological: LBR-101 High Dose
Subcutaneously Administered High Dose LBR-101 Monthly x 3
Experimental: LBR-101 Low Dose
Subcutaneous Low Dose LBR-101 Administered Monthly x 3
Biological: LBR-101 Low Dose
Subcutaneously Administered Low Dose LBR-101 Monthly x 3
Placebo Comparator: Placebo
Subcutaneous Placebo Administered Monthly x 3
Biological: Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025556

Contacts
Contact: Elizabeth Lotz, BS MBA (843) 722-8330 Elotz@NCGS.com
Contact: Janice Durden, BS MBA (843) 722-8330 Jdurden@NCGS.com

  Show 49 Study Locations
Sponsors and Collaborators
Labrys Biologics Inc.
NCGS, Inc.
  More Information

No publications provided

Responsible Party: Labrys Biologics Inc.
ClinicalTrials.gov Identifier: NCT02025556     History of Changes
Other Study ID Numbers: LBR-101-022
Study First Received: December 20, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Labrys Biologics Inc.:
High Frequency Episodic Migraine Headache
Episodic Migraine Headache
Migraine Headache

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014