A Study to Explore the Long-Term Safety of TEV-48125 (Fremanezumab) for the Prevention of Cluster Headache



Status:Enrolling by invitation
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:2/20/2019
Start Date:April 27, 2017
End Date:October 9, 2021

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A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache

This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH.
Patients who complete the pivotal studies and enroll into the current study will visit the
investigational center for IMP administration, safety and efficacy assessments, and blood and
urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses.
Patients will return to the investigational center for a follow-up visit to evaluate ADAs,
fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant
medications) approximately 7.5 months after the last dose of IMP.


Inclusion Criteria:

- The patient completes either the Phase 3 pivotal study for ECH (Study
TV48125-CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057)
without important protocol deviations related to patient safety and patient
compliance.

- Prior to 15 June 2018, patients from the ECH study and the CCH study were enrolled.
After 15 June 2018, only patients who participated in the ECH study (Study
TV48125-CNS-30056) will be enrolled for active treatment.

- In addition, patients who do not complete the pivotal efficacy studies, and patients
who complete the pivotal efficacy studies but will not continue treatment during this
long-term safety study, will be offered to enroll in this study for the purpose of
evaluating ADAs, and safety (adverse events and concomitant medications) approximately
7.5 months after administration of the last dose of the IMP.

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- Any finding that, in the judgment of the investigator, is a clinically significant
abnormality, including serum chemistry, hematology, coagulation, and urinalysis test
values (abnormal tests may be repeated for confirmation)

- Additional criteria apply, please contact the investigator for more information
We found this trial at
32
sites
New Haven, Connecticut
2486
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New Haven, CT
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Albuquerque, New Mexico 87102
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Amherst, NY
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Ann Arbor, Michigan
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Ann Arbor, MI
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Auchenflower,
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Aurora, CO
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Canoga Park, California
35
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Canoga Park, CA
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Chicago, Illinois
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Chicago, IL
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Cleveland, OH
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Colorado Springs, Colorado
802
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Colorado Springs, CO
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Columbus, GA
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817
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Denver, CO
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Englewood, Colorado
815
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Gainesville, Florida
2105
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Gainesville, FL
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Las Vegas, Nevada
217
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Las Vegas, NV
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Lebanon, New Hampshire
2515
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Lebanon, NH
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New York, New York
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New York, NY
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Orlando, FL
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Ormond Beach, Florida
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Phoenix, Arizona
343
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Princeton, New Jersey
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Raleigh, North Carolina
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Raleigh, NC
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Richmond, Texas 77307
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Saint Petersburg, Florida
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Saint Petersburg, FL
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Salisbury, North Carolina
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Santa Monica, California
27
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Santa Monica, CA
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Savannah, Georgia 31406
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Stamford, Connecticut
2455
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Stanford, California
328
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Stanford, CA
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Tampa, Florida
2136
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Tampa, FL
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Virginia Beach, Virginia
2350
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Virginia Beach, VA
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