A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
- Conditions
- migraineheadache10019231
- Registration Number
- NL-OMON56148
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Participants Rolling Over from the Pivotal Efficacy Trials may be included only
if they meet all of the following criteria:
a. Completion of the pivotal efficacy trial and in the opinion of the
Investigator/Sponsor able to complete the trial in a safe and compliant way
b. Participant's parent(s) or legal guardian(s) must give written informed
consent, and the participant 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. Participant may continue with a stable dose/regimen of the preventive
medication they were taking during the pivotal efficacy trials
d. Willing and able to comply with trial restrictions and to remain at the
clinic for the required duration during the trial period and willing to
return to the clinic for the follow-up evaluation as specified in this
protocol
e. Participant continues to meet appropriate criteria carried forward
from the pivotal efficacy trial, as follows:
f. Females who are postmenarchal or >=12 years of age may be included only if
they have a negative beta-human chorionic gonadotropin (β-HCG)
test before day 1 or are sterile
g. 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, at least 2 months before day 1)
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
h. Receipt of all recommended age-appropriate vaccines according to
local standard of care and schedule
i. Good health, determined by a medical and psychiatric history, medical
examination, 12-lead ECG, serum chemistry, hematology, coagulation,
urinalysis, and serology
j. Weight of at least 17.0 kg on the day of trial enrollment
k. BMI ranging from the 5th to 120% of the 95th percentile, incl. at
day1, based on the local standard
Participants Rolling Over from Trial TV48125-CNS-10141: may be
included only if they meet all of the following criteria
a. Participant is male/female, 6 - 17 years old (inclusive)
b. Written informed consent is obtained from each participant's parent or
legal guardian and written assent (according to local regulations) is
obtained from each participant. 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. 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/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)
d. Females who are postmenarchal or >=12 years of age may be included
only if they have a negative β-HCG test before day 1 or are sterile
e. Females who are postmenarchal or >=12 years of age and sexually<b
Participants from the Pivotal Efficacy Trials (any criteria met):
a. Significant abnormal finding on trial entry (e.g. hematology), repeat
abnormal tests for confirmation
b. Pregnant or nursing
c. Abnormal clinically significant finding on day 1 12-lead ECG
d. One of the following criteria is met:
e. Use of medications containing opioids (incl. codeine), barbiturates
(incl. Fiorinal®, any other combination containing butalbital) for
migraine treatment during the 3 months prior to screening visit day
f. Use of 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 1
g. Any clinically significant disease (e.g. cardiovascular), or
complications of an infection
h. History of clinically significant psychiatric condition/history of a
suicide attempt/history of suicidal ideation with a specific plan within
the past 2 years, at the discretion of the investigator
i. Ongoing infection/known history of e.g. HIV infection/tuberculosis,
Lyme disease, chronic hepatitis B or C, or a known infection of
coronavirus disease 2019 (COVID-19)
j. Past or current history of cancer
k. History of hypersensitivity reactions to injected proteins, incl. mAbs,
history of Stevens-Johnson Syndrome, toxic epidermal necrolysis
syndrome, or the participant in concomitantly using lamotrigine
l. Current participation in another IMP/medical device trial
m. Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test
confirmation, or suspected hepatocellular damage (fulfilling Hy's law)
n. Serum creatinine > 1.5× the ULN, clinically significant proteinuria
(urine dipstick +4), an estimated glomerular filtration rate (eGFR) of
<75 mL/min/1.73 m2, as calculated by the revised Schwartz formula
(eGFR=[0.413×Ht]/serum creatinine), or evidence of renal disease
o. Participant cannot fully participate in/successfully complete the trial
for its full duration for any of the following reasons:
-In custody due to an administrative or a legal decision or in residential
treatment
-Participant/caregiver unable to be contacted in case of emergency
-Presence of any other condition, which makes the participant
inappropriate for trial inclusion
-Participant is a relative of a trial center or sponsor employee who is
directly involved in the trial
p. Vulnerable participants (eg, people in detention) that are vulnerable
due to other conditions than age
q. Receipt of a live attenuated vaccine (eg, intranasal flu vaccine) within
the 12-week period prior to day 1. Note: If a medical need arises during
the trial, the participant may receive a live attenuated vaccine.
r. The participant has a known hypersensitivity to the active substance
or to any of the excipients of the trial drug.
s. The participant has a current or past medical history of hemiplegic
migraine.
Participants from Trial TV48125-CNS-10141 (any criteria met):
a. Use of an intervention/device for the treatment of migraine or in the
head or neck area for any condition during the 2 months prior to day 1.
b. Any clinically significant disease (e.g. cardiovascular)/complications
of an infection
c. Current history of clinically significant psychiatric condition/history of
a suicide attempt/suicidal ideation with a specific plan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>-Occurrence of adverse events throughout the trial, including local<br /><br>injection site reactions/pain<br /><br>-Changes from baseline in clinical laboratory (serum chemistry,<br /><br>hematology, coagulation, and urinalysis) test results and height and<br /><br>weight measurements taken at V5, V8, and at the end of treatment<br /><br>(V11)<br /><br>-Abnormal standard 12-lead electrocardiogram findings at each trial visit<br /><br>up to the end of treatment (V11)<br /><br>-Changes from baseline in vital signs (pulse, systolic and diastolic blood<br /><br>pressure, temperature, and respiratory rate) at each trial visit up to the<br /><br>end of treatment (V11)<br /><br>-Abnormal physical examination findings at trial visits V6, V7, V11, and<br /><br>V12<br /><br>-Suicidal ideation and behavior as suggested by the Columbia-Suicide<br /><br>Severity Rating Scale throughout the trial</p><br>
- Secondary Outcome Measures
Name Time Method