A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

NCT ID: NCT03347188

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-18
• Study Completion Date: 2020-06-03

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult participants aged 18 to 70 years, inclusive, for the prevention of PTH. The study will include a double-blind (DB) treatment period (12 weeks) and an open-label (OL) treatment period (12 weeks).

Conditions

Post-Traumatic Headache

Keywords

posttraumatic headache (PTH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Fremanezumab

Participants will receive fremanezumab 675 milligrams (mg) administered as 3 subcutaneous (SC) injections (225 mg/1.5 milliliters \[mL\] each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who complete the DB treatment period and continue into the OL treatment period will receive fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.

Group Type: EXPERIMENTAL

Fremanezumab

Intervention Type: DRUG

Fremanezumab will be administered per dose and schedule specified in the arm.

Placebo

Participants will receive placebo matching to fremanezumab administered as 3 SC injections (1.5 mL each) at randomization (Week 0), Weeks 4, and 8 during the DB treatment period. Participants who complete the DB treatment period and continue into the OL treatment period will receive fremanezumab 675 mg administered as 3 SC injections (225 mg/1.5 mL each) at Weeks 12, 16, and 20 during the OL treatment period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Interventions

Fremanezumab

Fremanezumab will be administered per dose and schedule specified in the arm.

Intervention Type: DRUG

Placebo

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Intervention Type: DRUG

Other Intervention Names

TEV-48125

Eligibility Criteria

Inclusion Criteria

• The participant has a body weight greater than or equal to (≥) 45 kilograms (kg).
• Traumatic injury to the head has occurred, defined as a structural or functional injury resulting from the action of external forces.
• The participant has a diagnosis of PTH.
• The participant is not using preventive medications for headache.
• Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 weeks after the last study drug administration. Men must be sterile or, if they are potentially fertile or reproductively competent (that is, 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 and for 30 weeks after the last study drug administration.

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

Exclusion Criteria

• The participant 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. Brain images with structurally insignificant changes, as discussed and approved by the sponsor, will be reviewed by the sponsor on a case-by-case basis.
• The participant has PTH attributed to craniotomy.
• The participant has whiplash and subsequent headache but no history of head injury or concussion.
• The participant is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
• The participant has had exposure to a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway (erenumab, eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit.
• The participant is currently being treated with onabotulinumtoxinA (for example, Botox, Dysport, Xeomin) application in the head or neck or received any such injection during the 3 months prior to the screening visit.
• The participant has been implanted with any electronic devices for headache prevention during the 3 months prior to the screening visit or is currently using any implanted or externally applied stimulator or device.
• The participant has been treated with a nerve block for head and/or neck during the 3 months prior to the screening visit.
• The participant 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 14065

Phoenix, Arizona, United States

Teva Investigational Site 14069

Scottsdale, Arizona, United States

Teva Investigational Site 14048

Little Rock, Arkansas, United States

Teva Investigational Site 30236

Little Rock, Arkansas, United States

Teva Investigational Site 14052

Long Beach, California, United States

Teva Investigational Site 14053

Los Angeles, California, United States

Teva Investigational Site 14060

San Diego, California, United States

Teva Investigational Site 14054

San Francisco, California, United States

Teva Investigational Site 14045

Fairfield, Connecticut, United States

Teva Investigational Site 14063

Miami, Florida, United States

Teva Investigational Site 14041

North Miami, Florida, United States

Teva Investigational Site 14056

Tampa, Florida, United States

Teva Investigational Site 14057

Riverwoods, Illinois, United States

Teva Investigational Site 14067

Indianapolis, Indiana, United States

Teva Investigational Site 14058

Louisville, Kentucky, United States

Teva Investigational Site 14061

Waltham, Massachusetts, United States

Teva Investigational Site 14051

Kansas City, Missouri, United States

Teva Investigational Site 14043

Springfield, Missouri, United States

Teva Investigational Site 14046

St Louis, Missouri, United States

Teva Investigational Site 14119

Albany, New York, United States

Teva Investigational Site 14229

Amherst, New York, United States

Teva Investigational Site 14047

New York, New York, United States

Teva Investigational Site 14118

The Bronx, New York, United States

Teva Investigational Site 14114

Durham, North Carolina, United States

Teva Investigational Site 14059

Salisbury, North Carolina, United States

Teva Investigational Site 14049

Portland, Oregon, United States

Teva Investigational Site 14064

Philadelphia, Pennsylvania, United States

Teva Investigational Site 14040

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 14230

Nashville, Tennessee, United States

Teva Investigational Site 14055

Dallas, Texas, United States

Teva Investigational Site 14050

Waco, Texas, United States

Teva Investigational Site 14113

Spokane, Washington, United States

Teva Investigational Site 14044

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TV48125-CNS-20024

Identifier Type: -

Identifier Source: org_study_id