A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age
- Registration Number
- NCT04464707
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).
Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM 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 75 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 298
- 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 ≥15 headache days per month on average during the 3 months prior to screening (visit 1).
- The participant or parent/caregiver maintain a prospectively collected headache diary
NOTE: Additional criteria apply; please contact the investigator for more information.
- 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 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, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years must be excluded.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fremanezumab Fremanezumab Participants weighing ≥ threshold will receive Dose A subcutaneously monthly for 3 months. Participants weighing \< threshold will receive Dose B subcutaneously monthly for 3 months. Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Mean change in the monthly average number of migraine days after the first dose of study drug Baseline - Month 3
- Secondary Outcome Measures
Name Time Method Number of adverse events Baseline - Month 3 including local injection site reaction/pain
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings Baseline - Month 3 Incidence of abnormal vital signs Baseline - Month 3 (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Number of participants with clinically significant changes in laboratory values Baseline, Month 1, and Month 3 Incidence of abnormal physical examination findings Baseline - Month 3 Yes/No suicidality ideation 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.
Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug Baseline - Month 3 Proportion of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug Baseline - Month 3 Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug Baseline - Month 3 Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug 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.
Mean change PedsQL after administration of the first dose of study drug 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.Proportion of participants developing antidrug antibodies (ADAs) throughout the study Baseline - Month 3 The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Trial Locations
- Locations (89)
Teva Investigational Site 14281
🇺🇸Little Rock, Arkansas, United States
Teva Investigational Site 14253
🇺🇸Banning, California, United States
Teva Investigational Site 14370
🇺🇸Loma Linda, California, United States
Teva Investigational Site 14322
🇺🇸Los Angeles, California, United States
Teva Investigational Site 14361
🇺🇸Sacramento, California, United States
Teva Investigational Site 14319
🇺🇸Aurora, Colorado, United States
Teva Investigational Site 14368
🇺🇸Colorado Springs, Colorado, United States
Teva Investigational Site 14244
🇺🇸Jacksonville, Florida, United States
Teva Investigational Site 14325
🇺🇸Miami, Florida, United States
Teva Investigational Site 14250
🇺🇸West Palm Beach, Florida, United States
Scroll for more (79 remaining)Teva Investigational Site 14281🇺🇸Little Rock, Arkansas, United States