A Study Comparing 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of PPTH



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:2/20/2019
Start Date:December 17, 2017
End Date:December 11, 2019
Contact:Teva U.S. Medical Information
Email:USMedInfo@tevapharm.com
Phone:1-888-483-8279

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A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double Blind, Placebo Controlled, Parallel Group Study Comparing the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of Persistent Posttraumatic Headache (PPTH)

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group
study to evaluate the safety and efficacy of fremanezumab in adult patients aged 18 to 70
years, inclusive, for the prevention of PPTH. Patients will provide written informed consent
and during study visits they will use an electronic diary application daily, to report their
headache status and other health information. Efficacy and immunogenicity status will be
captured periodically and at study termination. The safety will be evaluated through adverse
event report, concomitant medication inquiries, ECGs, clinical laboratory tests and physical
examination. Additional evaluations will include pharmacokinetic, biomarker, and
pharmacogenomics.


Inclusion Criteria:

- The patient has a body weight is greater than 99 lbs.

- Traumatic injury to the head has occurred, defined as a structural or functional
injury resulting from the action of external forces.

- The patient has a diagnosis of PPTH

- The patient is not using preventive medications for headache

- Women of childbearing potential 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 or reproductively
competent (ie, not surgically or congenitally sterile) and their female partners are
of childbearing potential, must use, together with their female partners, acceptable
birth control methods for the duration of the study.

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

Exclusion Criteria:

- The patient has a previous history of brain imaging showing evidence of intracerebral
hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a
consequence of the traumatic head injury.

- The patient has PPTH attributed to craniotomy.

- The patient has whiplash with only neck pain and no persistent headache >3 months
after whiplash.

- The patient is using analgesic medications containing opioids (including codeine) or a
barbiturate on average more than 15 days per month.

- The patient is currently using or has prior exposure to any calcitonin gene-related
peptide (CGRP) antibody, any antibody to the CGRP receptor.

- The patient has received onabotulinmumtoxinA (eg, Botox, Dysport) application in the
head or neck during the previous 3 months before screening.

- The patient has been implanted with any devices for headache prophylaxis during the
previous 3 months before screening.

- The patient has been treated with a nerve block for head and/or neck during the
previous 3 months before screening.

- The patient is a pregnant or lactating woman or plans to become pregnant during the
study.

NOTE- Additional criteria apply, please contact the investigator for more information
We found this trial at
26
sites
Kansas City, Missouri
Phone: +1 816 861 4700 (56622)
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Durham, North Carolina
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Fairfield, Connecticut
Phone: 203-333-1151
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Indianapolis, Indiana
Phone: 317-537-6088
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Little Rock, Arkansas 72205
Phone: 501-224-1348
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Long Beach, California
Phone: 714-799-7799
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Los Angeles, California
Phone: 818-439-6227
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Louisville, Kentucky 40291
Phone: 502-899-6782
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Miami, Florida
Phone: 305-243-6090
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Morgantown, West Virginia
Phone: 304-293-3527
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New York, New York
Phone: 212-774-2138
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North Miami, Florida
Phone: 954-962-1355
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Philadelphia, Pennsylvania
Phone: 215-955-2243
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Phoenix, Arizona
Phone: 602-258-3354
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Pittsburgh, Pennsylvania
Phone: +1-412-650-6155 (142)
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Portland, Oregon
Phone: 503-216-1150
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Riverwoods, Illinois 60015
Phone: 847-374-9399
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Saint Louis, Missouri
Phone: 314-251-8890
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Salisbury, North Carolina
Phone: 704-638-9000
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San Diego, California
Phone: 858-657-7030
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San Francisco, California
Phone: 415-673-4600
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Spokane, Washington
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Springfield, Missouri
Phone: 417-883-7889
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Tampa, Florida
Phone: 813-353-9613
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Waco, Texas
Phone: 254-752-6581
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Watertown, Massachusetts
Phone: 617-636-5848
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