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A Study Comparing 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of PPTH

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ClinicalTrials.gov Identifier: NCT03347188
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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 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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Drug: Fremanezumab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 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 Comparing the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of Persistent Posttraumatic Headache (PPTH)
Actual Study Start Date : December 17, 2017
Estimated Primary Completion Date : December 11, 2019
Estimated Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.
Drug: Fremanezumab
1 subcutaneous dose regimen
Other Name: TEV-48125

Placebo Comparator: Placebo
675 mg of placebo administered as 3 sc injections (225 mg/1.5 mL each ) at week 0,week, and week 8.
Drug: Placebo
1 subcutaneous dose regimen




Primary Outcome Measures :
  1. mean change in the monthly average number of headache days [ Time Frame: Baseline-Week 12 ]

Secondary Outcome Measures :
  1. proportion of patients reaching at least 50% reduction in the monthly average number of headache days of any severity [ Time Frame: Baseline-Week 12 ]
  2. 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 ]
  3. 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.

  4. occurrence of adverse events [ Time Frame: 44 weeks ]
  5. Number (%) of patients who did not complete the study [ Time Frame: Day 56 ]
  6. 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 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


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


Contacts
Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

  Show 25 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     History of Changes
Other Study ID Numbers: TV48125-CNS-20024
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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. ):
persistent posttraumatic headache (PPTH)

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases