A Study to Test if Fremanezumab Reduces Headache in Patients With Posttraumatic Headache (PTH)
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| ClinicalTrials.gov Identifier: NCT03347188 |
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Recruitment Status :
Completed
First Posted : November 20, 2017
Last Update Posted : September 10, 2020
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Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )
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Brief Summary:
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 PTH. 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. All patients will continue the DB period in an open label period during 12 weeks with a monthly dose of 675 mg sc.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-Traumatic Headache | Drug: Fremanezumab Drug: Placebo | Phase 2 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 87 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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) |
| Actual Study Start Date : | November 17, 2017 |
| Actual Primary Completion Date : | March 13, 2020 |
| Actual Study Completion Date : | June 3, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fremanezumab
675 mg of fremanezumab administered as 3 sc injections (225 mg/1.5 mL each ) at week 0, week 4, and week 8.
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Drug: Fremanezumab
1 subcutaneous dose regimen
Other Name: TEV-48125 |
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Placebo Comparator: Placebo
4.5 mL of placebo administered as 3 sc injections (1.5 mL each ) at week 0,week 4, and week 8.
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Drug: Placebo
1 subcutaneous dose regimen |
Primary Outcome Measures :
- mean change from baseline (run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of the IMP [ Time Frame: Baseline-Week 12 ]
Secondary Outcome Measures :
- proportion of patients reaching at least 50% reduction in the monthly average number of headache days of any severity [ Time Frame: Baseline-Week 12 ]
- mean change in the number of headache days of at least moderate severity [ Time Frame: during the first 4-week period, the 5- to 8-week period, and the 9- to 12-week period after the first dose ]
- mean change in disability score, as measured by the 6-item Headache Impact Test (HIT-6) [ Time Frame: Baseline, Week 12 after the first dose ]Six questions asked about the effect the headache has on normal daily life and ability to function. Each can be rated: Never (6 points), Rarely (8 points), Sometimes (10 points), Very often (11 points), Always (13 points). A higher total number represents a worse outcome.
- occurrence of adverse events [ Time Frame: 28 weeks ]
- Number (%) of patients who did not complete the study [ Time Frame: Day 56 ]
- Number (%) of patients who did not complete the study due to adverse events [ Time Frame: Day 56 ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 PTH
- 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. 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 patient has PTH attributed to craniotomy.
- The patient has whiplash and subsequent headache but no history of head injury or concussion.
- The patient is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
- The patient has had exposure to a mAb targeting the CGRP pathway (erenumab,eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit.
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347188
Locations
Show 31 study locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
| Study Director: | Teva Medical Expert, MD | Teva Pharmaceuticals USA |
| Responsible Party: | Teva Branded Pharmaceutical Products R&D, Inc. |
| ClinicalTrials.gov Identifier: | NCT03347188 |
| Other Study ID Numbers: |
TV48125-CNS-20024 |
| First Posted: | November 20, 2017 Key Record Dates |
| Last Update Posted: | September 10, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. ):
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posttraumatic headache (PTH) |
Additional relevant MeSH terms:
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Post-Traumatic Headache Headache Pain Neurologic Manifestations Headache Disorders, Secondary |
Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |