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A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458857
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).

Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab.

The total duration of the study is planned to be up to 36 months.


Condition or disease Intervention/treatment Phase
Migraine Drug: Fremanezumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : November 8, 2023
Estimated Study Completion Date : November 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fremanezumab
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
 Drug: Fremanezumab
Dose A or Dose B subcutaneous
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in the monthly average number of migraine days after the first dose of study drug [ Time Frame: Baseline - Month 3 ]

Secondary Outcome Measures :
  1. Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
  2. Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
  3. Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug [ Time Frame: Baseline - Month 3 ]
  4. Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug [ Time Frame: Baseline and Month 3 ]
    The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.

  5. Mean change PedsQL after administration of the first dose of study drug [ Time Frame: Baseline - Month 3 ]

    Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:

    0=never a problem;

    1. almost never a problem;
    2. sometimes a problem;
    3. often a problem;
    4. almost always a problem.

  6. Number of adverse events [ Time Frame: Baseline - Month 3 ]
    including local injection site reaction/pain

  7. Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings [ Time Frame: Baseline - Month 3 ]
  8. Incidence of abnormal vital signs [ Time Frame: Baseline - Month 3 ]
    (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements

  9. Number of participants with clinically significant changes in laboratory values [ Time Frame: Baseline, Month 1, and Month 3 ]
  10. Incidence of abnormal physical examination findings [ Time Frame: Baseline - Month 3 ]
  11. Yes/No suicidality ideation [ Time Frame: Screening - Month 3 ]
    Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.

  12. Number of participants developing antidrug antibodies (ADAs) throughout the study [ Time Frame: Baseline - Month 3 ]
    The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).
  • The participant or parent/caregiver maintain a prospectively collected headache diary
  • The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as <4 headache-free days during the 28-day baseline period.

NOTE: Additional criteria apply; please contact the investigator for more information.

Exclusion Criteria:

  • The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
  • The participant or parent/caregiver maintain a prospectively collected headache diary
  • The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
  • The participant has a current history of a clinically significant psychiatric condition, any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator.
  • The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
  • The participant has a past or current history of cancer.
  • The participant is pregnant or nursing.
  • The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
  • The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
  • The patient has a current or past medical history of hemiplegic migraine.

NOTE: Additional criteria apply; please contact the investigator for more information.

Contacts and Locations
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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): NCT04458857


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

Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT04458857    
Other Study ID Numbers: TV48125-CNS-30083
2019-002055-42 ( EudraCT Number )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
episodic migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases