2024-512837-34-00
Active, not recruiting
Phase 3
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
Teva Branded Pharmaceutical Products R&D LLC22 sites in 6 countries249 target enrollmentStarted: October 4, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Enrollment
- 249
- Locations
- 22
- Primary Endpoint
- Safety: Occurrence of adverse events throughout the trial, including local injection site reactions/pain
Overview
Brief Summary
To evaluate the long-term safety and tolerability of subcutaneous test IMP in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal trial)
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants Rolling Over from the Pivotal Efficacy Trials may be included only if they meet all of the following criteria: 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
- •Weight of at least 17.0 kg on the day of trial enrollment
- •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
- •Participants Rolling Over from Trial TV48125-CNS-10141: may be included only if they meet all of the following criteria; Participant is male/female, 6 - 17 years old (inclusive)
- •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
- •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)
- •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
- •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 the 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 the IMP
- •The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule
- •The participant is in good health as determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, urinalysis, and serology
Exclusion Criteria
- •Participants from the Pivotal Efficacy Trials (any criteria met): Significant abnormal finding on trial entry (e.g. hematology), repeat abnormal tests for confirmation
- •Past or current history of cancer
- •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
- •Current participation in another IMP/medical device trial
- •Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test confirmation, or suspected hepatocellular damage (fulfilling Hy's law)
- •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
- •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
- •Vulnerable participants (eg, people in detention) that are vulnerable due to other conditions than age
- •Receipt of a live attenuated vaccine (eg, intranasal flu vaccine) within the 12-week period prior to day
- •Note: If a medical need arises during the trial, the participant may receive a live attenuated vaccine.
Outcomes
Primary Outcomes
Safety: Occurrence of adverse events throughout the trial, including local injection site reactions/pain
Safety: Occurrence of adverse events throughout the trial, including local injection site reactions/pain
Changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results and height and weight measurements taken at V5, V8, and at the end of treatment (V11)
Changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results and height and weight measurements taken at V5, V8, and at the end of treatment (V11)
Abnormal standard 12-lead electrocardiogram findings at each trial visit up to the end of treatment (V11)
Abnormal standard 12-lead electrocardiogram findings at each trial visit up to the end of treatment (V11)
Changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, temperature, and respiratory rate) at each trial visit up to the end of treatment (V11)
Changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, temperature, and respiratory rate) at each trial visit up to the end of treatment (V11)
Abnormal physical examination findings at trial visits V6, V7, V11, and V12
Abnormal physical examination findings at trial visits V6, V7, V11, and V12
Suicidal ideation and behavior as suggested by the Columbia-Suicide Severity Rating Scale throughout the trial
Suicidal ideation and behavior as suggested by the Columbia-Suicide Severity Rating Scale throughout the trial
Secondary Outcomes
- Efficacy: Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of headache days of at least moderate severity during the 4-week periods after V2, V6, and V10
- Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of migraine days during the 4-week periods after V2, V6, and V10
- Proportion of participants reaching at least 50% reduction in the number of migraine days during the 4-week periods after V2, V6, and V10
- Proportion of participants reaching at least 50% reduction in the number of headache days of at least moderate severity during the 4- week periods after V2, V6, and V10
- Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of days of use of any acute headache medications during the 4-week periods after V2, V6, and V10
- Mean change from baseline (day 1) in migraine-related disability score, as measured by the PedMIDAS questionnaire at V5, V8, V11, and V12
- Proportion of participants developing ADAs throughout the trial. The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows
Investigators
Medical Information
Scientific
Teva Branded Pharmaceutical Products R&D LLC
Study Sites (22)
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