A Trial to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age
- Conditions
- Chronic MigraineMedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: LLTClassification code 10066636Term: Chronic migraineSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-002053-33-DE
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 278
a. The participants is a male or female between the ages of 6 to 17 years (inclusive) on the day of randomization to test IMP / placebo IMP.
b. The participant’s parent(s) or legal guardian(s) must give written informed consent, and the participants must give assent (in accordance with local regulations). Note: In some countries, participants aged 15 to 17 years (inclusive) may give written informed consent; however, the participant´s parent(s) or legal guardian(s) must be informed, per local regulations.
c. 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).
d. The participants or parent/caregiver has maintained a prospectively collected headache diary during a 28-day baseline period in which headache days were recorded on 15 or more days, and 8 or more of these headache days had at least 1 of the following migraine characteristics:
-head pain of moderate to severe intensity lasting for 2 or more hours in duration and accompanied by either throbbing quality, predominantly unilateral location, or aggravation with normal activities.
-headache is accompanied by a migraine-associated symptom, such as photophobia, phonophobia, abdominal pain, nausea, or vomiting.
-headache is preceded by an aura, as described by ICHD-3 criteria.
-headache was treated by a nonsteroidal anti-inflammatory drug (NSAID), paracetamol, triptan, or ergot preparation.
e. This criterion was deleted
f. Not using migraine preventive medications or using no more than 2 migraine preventive medication for migraine or other medical condition, as long as the dose and regimen have been stable for at least 2 months prior to screening (visit 1).
Note: A person is considered to be not using migraine preventive medications when at least 5 half-lives have passed since the last use of the medication prior to screening (visit 1) or at least 4 months have passed since the last use of Onabotulinum toxin A or B prior to screening (visit 1). The use of other agents that are not
included in Appendix C but used for migraine prevention is permitted during the study; however, these patients will not be counted towards the 30% patient limit threshold.
g. Females who are postmenarchal or =12 years of age may be included only if they have a negative beta-human chorionic gonadotropin (ß-HCG) test at baseline or are sterile.
h. Females who are postmenarchal or =12 years of age and sexually active must use highly effective birth control methods with their male partners for the duration of the trial (ie, starting at screening) and for 6 months after the last dose of IMP. Males who are sexually active with female partners must use a condom for the duration of the trial and for 6 months after the last administration of IMP. Further details are included in Section 13.1.
i. The participant/caregiver has demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 out of 28 days (approximately 75% diary compliance).
j. The participant is in good health, as determined by a medical and psychiatric history, medical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, coagulation, urinalysis, and serology.
k. The participants/ca
a. 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.
b. 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 are for any condition during the 2 months prior to the day of the screening visit.
c. The participant has any clinically significant cardiovascular (including congenital cardiac anomalies or thromboembolic events), endocrine, gastrointestinal, genitourinary, hematologic, hepatic, immunologic, neurologic, ophthalmic, pulmonary, renal disease, or complications of an infection, at the discretion of the investigator.
d. 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.
e. The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, chronic hepatitis B or C, or a known active infection of COVID-19.
f. The participant has a past or current history of cancer.
g. The participant is pregnant or nursing
h. The participant has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs), or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
i. The participant has participated in another trial of an IMP (or a medical device) within the 30 days (or 90 days for biologics) or 5 half-lives previous to the day of the screening visit (whichever is longer), or is currently participating in another trial of an IMP (or a medical device).
j. The participant has had exposure to a mAb targeting the calcitonin gene-related peptide (CGRP) pathway (erenumab, eptinezumab, galcanezumab, fremanezumab) during the 6 months previous to the day of the screening visit.
k. Previous participation in the Phase 1 pharmacokinetics trial
(Trial TV48125-CNS-10141).
l. In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant.
m. In the judgment of the investigator, the participant has a significantly abnormal finding during the 28-day baseline period, including hematology, blood chemistry, coagulation tests, or urinalysis values/findings (abnormal tests may be repeated for confirmation).
n. The participant has hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) more than 1.5× the upper limit of normal (ULN) during the 28-day baseline period, after confirmation in a repeat test, or suspected hepatocellular damage that fulfills the criteria for Hy’s law.
o. The participant has serum creatinine more than 1.5× the ULN, clinically significant proteinuria (urine dipstick +4), an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m2, as calculated by the revised Schwartz formula (eGFR=[0.413xHt]/Serum Creatinine), or evidence of renal disease during the 28-day baseline period.
p. The participant has any history of alcohol or drug abuse. The definition of alcohol or drug abuse, including marijuana, is based o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of test investigational medicinal product (IMP) as compared to placebo IMP for the preventive treatment of chronic migraine (CM);Secondary Objective: -To evaluate the safety and tolerability of test IMP in the preventive treatment of CM<br>-To further demonstrate the efficacy of test IMP as compared to placebo IMP for the preventive treatment of CM<br>-To evaluate the immunogenicity of test IMP and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to test IMP;Primary end point(s): Mean change from baseline (28-day baseline period) in the monthly average number of migraine days during the 12-week period after the first dose of IMP;Timepoint(s) of evaluation of this end point: 12 weeks after the first dose of IMP
- Secondary Outcome Measures
Name Time Method