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
Saint Louis, Missouri
Phone: 314-251-8890
1573
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from 91732
Saint Louis, MO
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Durham, North Carolina
2201
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Durham, NC
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Fairfield, Connecticut
Phone: 203-333-1151
2471
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Fairfield, CT
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Indianapolis, Indiana
Phone: 317-537-6088
1793
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Indianapolis, IN
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Kansas City, Missouri
Phone: +1 816 861 4700 (56622)
1341
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Kansas City, MO
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Little Rock, Arkansas 72205
Phone: 501-224-1348
1460
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Little Rock, AR
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Long Beach, California
Phone: 714-799-7799
23
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Long Beach, CA
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Los Angeles, California
Phone: 818-439-6227
13
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Los Angeles, CA
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Louisville, Kentucky 40291
Phone: 502-899-6782
1822
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Louisville, KY
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Miami, Florida
Phone: 305-243-6090
2320
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Miami, FL
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Morgantown, West Virginia
Phone: 304-293-3527
2122
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Morgantown, WV
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New York, New York
Phone: 212-774-2138
2432
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New York, NY
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North Miami, Florida
Phone: 954-962-1355
2319
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North Miami, FL
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Philadelphia, Pennsylvania
Phone: 215-955-2243
2375
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Philadelphia, PA
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Phoenix, Arizona
Phone: 602-258-3354
343
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Phoenix, AZ
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Pittsburgh, Pennsylvania
Phone: +1-412-650-6155 (142)
2119
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Pittsburgh, PA
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Portland, Oregon
Phone: 503-216-1150
827
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Portland, OR
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Riverwoods, Illinois 60015
Phone: 847-374-9399
1719
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Riverwoods, IL
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Salisbury, North Carolina
Phone: 704-638-9000
2117
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Salisbury, NC
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San Diego, California
Phone: 858-657-7030
105
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San Diego, CA
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San Francisco, California
Phone: 415-673-4600
355
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San Francisco, CA
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Spokane, Washington
939
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Spokane, WA
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Springfield, Missouri
Phone: 417-883-7889
1400
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Springfield, MO
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Tampa, Florida
Phone: 813-353-9613
2136
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Tampa, FL
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Waco, Texas
Phone: 254-752-6581
1221
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Waco, TX
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Watertown, Massachusetts
Phone: 617-636-5848
?
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Watertown, MA
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