Phase 2
N=87
A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)
Post-Traumatic Headache
Bottom Line
View on ClinicalTrials.gov: NCT03347188 ↗Enrolled (actual)
87
Serious AEs
3.5%
Results posted
Mar 2021
Primary outcome: Primary: 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 — -3.6; -5.1 days — p=0.1876
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fremanezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-3.6; -5.1 | 0.1876 |
| SECONDARY 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 |
5; 4 | — |
| SECONDARY 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 |
9; 11 | — |
| SECONDARY 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) |
8; 11; 8; 14; 14; 12 | — |
| SECONDARY 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) |
-3.6; -4.0; -3.7; -6.7; -5.2; -7.2 | — |
| SECONDARY 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 |
-6.9; -10.8 | — |
| SECONDARY 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 |
12; 11; 24; 26; 6; 6 | — |
| SECONDARY DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
31; 35 | — |
| SECONDARY OL Period: Number of Participants With TEAEs |
8; 6 | — |
| SECONDARY DB Period: Number of Participants Who Did Not Complete the Study |
15; 17; 1; 1 | — |
| SECONDARY OL Period: Number of Participants Who Did Not Complete the Study |
1; 1; 0; 0 | — |
| SECONDARY DB Period: Number of Participants Who Received Concomitant Medications |
43; 42 | — |
| SECONDARY OL Period: Number of Participants Who Received Concomitant Medications |
9; 7 | — |
| SECONDARY Number of Participants With Positive Findings on Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) |
0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Antidrug Antibodies (ADA) |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03347188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.