Clinical trial NCT03347188: A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)
Official title: A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double-Blind, Placebo-Controlled, Parallel-Group Study, Including an Open-Label Period, Evaluating the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab for the Treatment of Posttraumatic Headache (PTH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Headache
Keywords: posttraumatic headache (PTH)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: DB Period: Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Treatment Period After the First Dose of Fremanezumab
timeFrame: Baseline (Day -28 to Day -1), up to Week 12
Secondary outcomes:
measure: DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of Any Severity During 12-Week Treatment With Fremanezumab
timeFrame: Baseline (Day -28 to Day-1) up to Week 12
measure: DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Treatment With Fremanezumab
timeFrame: Baseline (Day -28 to Day-1) up to Week 12
measure: DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During First 4-Week (Month 1), 5- to 8-Week (Month 2), and 9- to 12-Week (Month 3)
timeFrame: Baseline (Day -28 to Day-1) up to Months 1, 2, and 3
measure: DB Period: Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the First 4-Week (Month 1), 5- to 8-Week (Month 2), and 9- to 12-Week (Month 3)
timeFrame: Baseline (Day -28 to Day -1), up to Months 1, 2, and 3
measure: DB Period: Change From Baseline in Disability Score, as Measured by the 6-Item Headache Impact Test (HIT-6) Total Score at Week 12 After the First Dose of Fremanezumab
timeFrame: Baseline (Day -28 to Day -1), Week 12
measure: DB Period: Number of Participants (Responder and Non-Responder) With the Patient Global Impression of Change (PGIC) Scale at Weeks 4, 8, and 12 After the First Dose of Fremanezumab
timeFrame: Weeks 4, 8, and 12
measure: DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Day -28 to -1) up to Week 12
measure: OL Period: Number of Participants With TEAEs
timeFrame: Week 12 up to Week 24
measure: DB Period: Number of Participants Who Did Not Complete the Study
timeFrame: Baseline (Day -28 to Day -1) up to Week 12
measure: OL Period: Number of Participants Who Did Not Complete the Study
timeFrame: Week 12 up to Week 24
measure: DB Period: Number of Participants Who Received Concomitant Medications
timeFrame: Baseline (Day -28 to Day -1) up to Week 12
measure: OL Period: Number of Participants Who Received Concomitant Medications
timeFrame: Week 12 up to Week 24
measure: Number of Participants With Positive Findings on Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
timeFrame: Baseline (Day -28 to Day -1) up to Week 24
measure: Number of Participants With Treatment-Emergent Antidrug Antibodies (ADA)
timeFrame: Baseline (Day -28 to Day -1) up to Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 14065
state: Arizona
city: Scottsdale
country: United States
facility: Teva Investigational Site 14069
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 14048
state: Arkansas
city: Little Rock
country: United States
facility: Teva Investigational Site 30236
state: Arkansas
city: Long Beach
country: United States
facility: Teva Investigational Site 14052
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14053
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 14060
state: California
city: San Francisco
country: United States
facility: Teva Investigational Site 14054
state: California
city: Fairfield
country: United States
facility: Teva Investigational Site 14045
state: Connecticut
city: Miami
country: United States
facility: Teva Investigational Site 14063
state: Florida
city: North Miami
country: United States
facility: Teva Investigational Site 14041
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 14056
state: Florida
city: Riverwoods
country: United States
facility: Teva Investigational Site 14057
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 14067
state: Indiana
city: Louisville
country: United States
facility: Teva Investigational Site 14058
state: Kentucky
city: Waltham
country: United States
facility: Teva Investigational Site 14061
state: Massachusetts
city: Kansas City
country: United States
facility: Teva Investigational Site 14051
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 14046
state: Missouri
city: Springfield
country: United States
facility: Teva Investigational Site 14043
state: Missouri
city: Albany
country: United States
facility: Teva Investigational Site 14119
state: New York
city: Amherst
country: United States
facility: Teva Investigational Site 14229
state: New York
city: Bronx
country: United States
facility: Teva Investigational Site 14118
state: New York
city: New York
country: United States
facility: Teva Investigational Site 14047
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 14114
state: North Carolina
city: Salisbury
country: United States
facility: Teva Investigational Site 14059
state: North Carolina
city: Portland
country: United States
facility: Teva Investigational Site 14049
state: Oregon
city: Philadelphia
country: United States
facility: Teva Investigational Site 14064
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 14040
state: Pennsylvania
city: Nashville
country: United States
facility: Teva Investigational Site 14230
state: Tennessee
city: Dallas
country: United States
facility: Teva Investigational Site 14055
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 14050
state: Texas
city: Spokane
country: United States
facility: Teva Investigational Site 14113
state: Washington
city: Morgantown
country: United States
facility: Teva Investigational Site 14044
state: West Virginia
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: