A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 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
- 292
- 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 participant 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 Dose A Fremanezumab Participants weighing \< threshold will receive Dose A subcutaneously monthly for 3 months. Fremanezumab Dose B Fremanezumab 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 - Week 12
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) Baseline - Month 3 including local injection site reaction/pain
Number of abnormal standard 12-lead electrocardiogram (ECG) findings assessed by investigator Baseline - Month 3 Number of abnormal standard 12-lead electrocardiogram (ECG) findings assessed by cardiologist Baseline - Month 3 Number of participants with any one or more potentially clinically significant (PCS) 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 Number of abnormal physical examination findings Baseline - Month 3 Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Baseline and 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 - Week 12 Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug Baseline - Week 12 Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug Baseline - Week 12 Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire Baseline and Week 12 The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. LS mean was calculated using ANCOVA. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.
Mean change PedsQL after administration of the first dose of study drug Baseline and Week 12 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.Number 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