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Assessment of LBR-101 In Chronic Migraine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT02021773
First received: December 20, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Chronic Migraine
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: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Mean change from baseline in the number of monthly cumulative headache hours of any severity on headache days relative to 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 ]
  • Safety as determined by the presence of Adverse events by treatment group [ Time Frame: 12 weeks after first dose of blinded study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change from baseline in the number of headache days of at least moderate severity relative to 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: 225
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 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 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 LBR-101 Monthly x 3
Placebo Comparator: Placebo
Subcutaneous Placebo Administered Monthly x 3
Biological: Placebo
Subcutaneously Administered Placebo (Vehicle) Monthly x 3

Detailed Description:

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.

  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.
  • 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.
  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: NCT02021773

  Show 59 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT02021773     History of Changes
Other Study ID Numbers: LBR-101-021
Study First Received: December 20, 2013
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Headache
Migraine
Chronic Migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014