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

Use our guide to learn which trials are right for you!

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
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Ann Arbor, Michigan
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Auchenflower,
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Canoga Park, California
?
mi
from
Canoga Park, CA
Click here to add this to my saved trials
Chicago, Illinois
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Englewood, Colorado
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Gainesville, Florida
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Las Vegas, Nevada
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lebanon, New Hampshire
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
New Haven, Connecticut
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York
?
mi
from
New York, NY
Click here to add this to my saved trials
Ormond Beach, Florida
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Princeton, New Jersey
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
Raleigh, North Carolina
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Texas 77307
?
mi
from
Richmond, TX
Click here to add this to my saved trials
Saint Petersburg, Florida
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salisbury, North Carolina
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
Santa Monica, California
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Stamford, Connecticut
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Stanford, California
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tampa, Florida
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Virginia Beach, Virginia
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials