A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

Description

This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult patients for the prevention of ECH.

Study Start Date

November, 30 2016

Estimated Completion Date

June 2018

Interventions

  • Drug: Fremanezumab - B
  • Drug: Fremanezumab - A
  • Drug: Placebo

Study ID

Teva Pharmaceutical Industries -- TV48125-CNS-30056

Status

Unknown

Trial ID

NCT02945046

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

300

Sponsor

Teva Pharmaceutical Industries

Inclusion Criteria

  • The patient has a history of ECH according to the International Classification of Headache Disorders
  • 3 beta criteria (Headache Classification Committee of the IHS 2013) for ?12 months prior to screening
  • The patient has a total body weight of ?45 kg (99 lbs.)
  • The patient is in good health in the opinion of the investigator
  • Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study
  • Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control
  • If a patient is receiving Botox, it should be in a stable dose regimen, considered as having ?2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.
  • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

  • The patient has used systemic steroids for any medical reason (including treatment of the current CH cycle within ?7 days prior to screening The patient has used an intervention/device (eg, scheduled nerve blocks) for headache during the 4 weeks prior to screening.
  • The patient has clinically significant hematological, renal, endocrine, immunologic, pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the discretion of the investigator.
  • The patient has evidence or medical history of clinically significant psychiatric issues determined at the discretion of the investigator.
  • The patient has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
  • The patient is pregnant or lactating.
  • The patient has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
  • The patient has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is known that the patient received placebo during the study.
  • The patient has a history of prior exposure to a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If patient has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the patient received placebo in order to be eligible for this study.
  • The patient is an employee of the sponsor/participating study center who is directly involved in the study or is the relative of such an employee.
  • The patient has an active implant for neurostimulation used in the treatment of CH.
  • The patient is a member of a vulnerable population (eg, people kept in detention).
  • The patient has a history of alcohol abuse prior to screening and/or drug abuse that in the investigator's opinion could interfere with the study evaluations or the patient's safety .
  • Additional criteria apply, please contact the investigator for more information

Gender

All

Ages

17 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (113)

Study Location Distance Name Phone Email
Teva Investigational Site 13812 - Stamford, Connecticut 17.9 miles None None None
Teva Investigational Site 13812 - Stamford, Connecticut 17.9 miles None None None
Teva Investigational Site 13812 - Stamford, Connecticut 17.9 miles None None None
Teva Investigational Site 13812 - Stamford, Connecticut 17.9 miles None None None
Teva Investigational Site 13817 - New York, New York 49.7 miles None None None
Teva Investigational Site 13817 - New York, New York 49.7 miles None None None
Teva Investigational Site 13817 - New York, New York 49.7 miles None None None
Teva Investigational Site 13817 - New York, New York 49.7 miles None None None
Teva Investigational Site 13820 - Princeton, New Jersey 94.9 miles None None None
Teva Investigational Site 13820 - Princeton, New Jersey 94.9 miles None None None
Teva Investigational Site 13820 - Princeton, New Jersey 94.9 miles None None None
Teva Investigational Site 13820 - Princeton, New Jersey 94.9 miles None None None
Teva Investigational Site 13824 - Philadelphia, Pennsylvania 133.3 miles None None None
Teva Investigational Site 13824 - Philadelphia, Pennsylvania 133.3 miles None None None
Teva Investigational Site 13824 - Philadelphia, Pennsylvania 133.3 miles None None None
Teva Investigational Site 13824 - Philadelphia, Pennsylvania 133.3 miles None None None
Teva Investigational Site 13831 - Lebanon, New Hampshire 175.0 miles None None None
Teva Investigational Site 13831 - Lebanon, New Hampshire 175.0 miles None None None
Teva Investigational Site 13831 - Lebanon, New Hampshire 175.0 miles None None None
Teva Investigational Site 13831 - Lebanon, New Hampshire 175.0 miles None None None
Teva Investigational Site 13816 - Amherst, New York 309.6 miles None None None
Teva Investigational Site 13816 - Amherst, New York 309.6 miles None None None
Teva Investigational Site 13816 - Amherst, New York 309.6 miles None None None
Teva Investigational Site 13816 - Amherst, New York 309.6 miles None None None
Teva Investigational Site 13822 - Virginia Beach, Virginia 338.4 miles None None None
Teva Investigational Site 13822 - Virginia Beach, Virginia 338.4 miles None None None
Teva Investigational Site 13822 - Virginia Beach, Virginia 338.4 miles None None None
Teva Investigational Site 13822 - Virginia Beach, Virginia 338.4 miles None None None
Teva Investigational Site 13825 - Cleveland, Ohio 435.4 miles None None None
Teva Investigational Site 13825 - Cleveland, Ohio 435.4 miles None None None
Teva Investigational Site 13825 - Cleveland, Ohio 435.4 miles None None None
Teva Investigational Site 13825 - Cleveland, Ohio 435.4 miles None None None
Teva Investigational Site 13809 - Raleigh, North Carolina 477.1 miles None None None
Teva Investigational Site 13809 - Raleigh, North Carolina 477.1 miles None None None
Teva Investigational Site 13809 - Raleigh, North Carolina 477.1 miles None None None
Teva Investigational Site 13809 - Raleigh, North Carolina 477.1 miles None None None
Teva Investigational Site 13818 - Ann Arbor, Michigan 545.6 miles None None None
Teva Investigational Site 13818 - Ann Arbor, Michigan 545.6 miles None None None
Teva Investigational Site 13818 - Ann Arbor, Michigan 545.6 miles None None None
Teva Investigational Site 13818 - Ann Arbor, Michigan 545.6 miles None None None
Teva Investigational Site 13839 - Salisbury, North Carolina 548.8 miles None None None
Teva Investigational Site 13839 - Salisbury, North Carolina 548.8 miles None None None
Teva Investigational Site 13839 - Salisbury, North Carolina 548.8 miles None None None
Teva Investigational Site 13839 - Salisbury, North Carolina 548.8 miles None None None
Teva Investigational Site 13819 - Seneca, South Carolina 695.2 miles None None None
Teva Investigational Site 13819 - Seneca, South Carolina 695.2 miles None None None
Teva Investigational Site 13819 - Seneca, South Carolina 695.2 miles None None None
Teva Investigational Site 13819 - Seneca, South Carolina 695.2 miles None None None
Teva Investigational Site 13826 - Chicago, Illinois 747.2 miles None None None
Teva Investigational Site 13826 - Chicago, Illinois 747.2 miles None None None
Teva Investigational Site 13826 - Chicago, Illinois 747.2 miles None None None
Teva Investigational Site 13826 - Chicago, Illinois 747.2 miles None None None
Teva Investigational Site 13838 - Savannah, Georgia 773.0 miles None None None
Teva Investigational Site 13838 - Savannah, Georgia 773.0 miles None None None
Teva Investigational Site 13838 - Savannah, Georgia 773.0 miles None None None
Teva Investigational Site 13838 - Savannah, Georgia 773.0 miles None None None
Teva Investigational Site 13833 - Columbus, Georgia 884.9 miles None None None
Teva Investigational Site 13833 - Columbus, Georgia 884.9 miles None None None
Teva Investigational Site 13833 - Columbus, Georgia 884.9 miles None None None
Teva Investigational Site 13829 - Ormond Beach, Florida 937.9 miles None None None
Teva Investigational Site 13829 - Ormond Beach, Florida 937.9 miles None None None
Teva Investigational Site 13829 - Ormond Beach, Florida 937.9 miles None None None
Teva Investigational Site 13829 - Ormond Beach, Florida 937.9 miles None None None
Teva Investigational Site 13810 - Gainesville, Florida 952.8 miles None None None
Teva Investigational Site 13810 - Gainesville, Florida 952.8 miles None None None
Teva Investigational Site 13810 - Gainesville, Florida 952.8 miles None None None
Teva Investigational Site 13810 - Gainesville, Florida 952.8 miles None None None
Teva Investigational Site 13815 - Orlando, Florida 992.3 miles None None None
Teva Investigational Site 13815 - Orlando, Florida 992.3 miles None None None
Teva Investigational Site 13815 - Orlando, Florida 992.3 miles None None None
Teva Investigational Site 13815 - Orlando, Florida 992.3 miles None None None
Teva Investigational Site 13840 - Tampa, Florida 1,056.0 miles None None None
Teva Investigational Site 13840 - Tampa, Florida 1,056.0 miles None None None
Teva Investigational Site 13840 - Tampa, Florida 1,056.0 miles None None None
Teva Investigational Site 13840 - Tampa, Florida 1,056.0 miles None None None
Teva Investigational Site 13830 - Saint Petersburg, Florida 1,072.9 miles None None None
Teva Investigational Site 13830 - Saint Petersburg, Florida 1,072.9 miles None None None
Teva Investigational Site 13830 - Saint Petersburg, Florida 1,072.9 miles None None None
Teva Investigational Site 13830 - Saint Petersburg, Florida 1,072.9 miles None None None
Teva Investigational Site 13828 - Plano, Texas 1,411.8 miles None None None
Teva Investigational Site 13828 - Plano, Texas 1,411.8 miles None None None
Teva Investigational Site 13828 - Plano, Texas 1,411.8 miles None None None
Teva Investigational Site 13828 - Plano, Texas 1,411.8 miles None None None
Teva Investigational Site 13837 - Aurora, Colorado 1,658.2 miles None None None
Teva Investigational Site 13837 - Aurora, Colorado 1,658.2 miles None None None
Teva Investigational Site 13837 - Aurora, Colorado 1,658.2 miles None None None
Teva Investigational Site 13836 - Denver, Colorado 1,665.3 miles None None None
Teva Investigational Site 13836 - Denver, Colorado 1,665.3 miles None None None
Teva Investigational Site 13836 - Denver, Colorado 1,665.3 miles None None None
Teva Investigational Site 13813 - Englewood, Colorado 1,666.4 miles None None None
Teva Investigational Site 13813 - Englewood, Colorado 1,666.4 miles None None None
Teva Investigational Site 13813 - Englewood, Colorado 1,666.4 miles None None None
Teva Investigational Site 13813 - Englewood, Colorado 1,666.4 miles None None None
Teva Investigational Site 13814 - Colorado Springs, Colorado 1,669.5 miles None None None
Teva Investigational Site 13814 - Colorado Springs, Colorado 1,669.5 miles None None None
Teva Investigational Site 13814 - Colorado Springs, Colorado 1,669.5 miles None None None
Teva Investigational Site 13827 - Albuquerque, New Mexico 1,856.4 miles None None None
Teva Investigational Site 13827 - Albuquerque, New Mexico 1,856.4 miles None None None
Teva Investigational Site 13827 - Albuquerque, New Mexico 1,856.4 miles None None None
Teva Investigational Site 13827 - Albuquerque, New Mexico 1,856.4 miles None None None
Teva Investigational Site 13834 - Phoenix, Arizona 2,179.5 miles None None None
Teva Investigational Site 13835 - Las Vegas, Nevada 2,270.3 miles None None None
Teva Investigational Site 13835 - Las Vegas, Nevada 2,270.3 miles None None None
Teva Investigational Site 13835 - Las Vegas, Nevada 2,270.3 miles None None None
Teva Investigational Site 13835 - Las Vegas, Nevada 2,270.3 miles None None None
Teva Investigational Site 13832 - Las Vegas, Nevada 2,278.1 miles None None None
Teva Investigational Site 13832 - Las Vegas, Nevada 2,278.1 miles None None None
Teva Investigational Site 13832 - Las Vegas, Nevada 2,278.1 miles None None None
Teva Investigational Site 13832 - Las Vegas, Nevada 2,278.1 miles None None None
Teva Investigational Site 13811 - Santa Monica, California 2,501.9 miles None None None
Teva Investigational Site 13811 - Santa Monica, California 2,501.9 miles None None None
Teva Investigational Site 13823 - Stanford, California 2,599.9 miles None None None
Teva Investigational Site 13823 - Stanford, California 2,599.9 miles None None None

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