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Study on the Effectiveness of Fremanezumab for Preventing Migraines in Children and Teens Aged 6 to 17

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called fremanezumab, also known by its code name PF-04427429, for the prevention of migraine in children and adolescents aged 6 to 17 years. Migraines are severe headaches that can cause intense throbbing or pulsing in one area of the head, often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The study aims to evaluate the long-term safety and how well patients tolerate fremanezumab when it is administered as a monthly injection under the skin.

Participants in the study will receive fremanezumab in the form of a solution for injection, either in a pre-filled pen or syringe. The study will last for a period of up to 36 months, during which participants will receive regular injections. Throughout the study, participants will be monitored for any side effects, including reactions at the injection site, and changes in their overall health, such as weight, height, and vital signs like blood pressure and heart rate. The study will also track the number of migraine days and the severity of headaches experienced by participants to assess the effectiveness of the treatment.

The goal of this trial is to gather information on the safety and effectiveness of fremanezumab in preventing migraines in young patients. By participating in this study, researchers hope to better understand how this medication can help reduce the frequency and severity of migraines in children and adolescents, ultimately improving their quality of life. The study will also look at any potential changes in the use of other headache medications and any impact on daily activities due to migraines.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Initial Assessment

    Upon joining the study, the participant undergoes an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and various tests such as blood tests and an electrocardiogram (ECG).

    The participant's weight and height are measured, and a headache diary is reviewed to ensure compliance with trial requirements.

  2. Step 2

    Medication Administration

    The participant receives the medication fremanezumab, which is administered as a subcutaneous injection. The medication is provided in a pre-filled pen or syringe, each containing 225 mg of the solution.

    The injections are given once a month throughout the trial period.

  3. Step 3

    Regular Monitoring

    The participant attends regular clinic visits for monitoring. These visits include assessments of vital signs, such as pulse, blood pressure, temperature, and respiratory rate.

    Blood tests and other laboratory tests are conducted to monitor the participant's health and detect any potential side effects.

  4. Step 4

    Evaluation of Treatment Effects

    The participant's response to the treatment is evaluated by tracking changes in the number of headache and migraine days. This is done through regular assessments and the use of a headache diary.

    The participant completes questionnaires to assess any changes in migraine-related disability.

  5. Step 5

    End of Treatment and Follow-Up

    At the end of the treatment period, a final assessment is conducted. This includes a physical examination, laboratory tests, and an ECG.

    The participant may be required to return for follow-up evaluations to monitor long-term effects and ensure safety.

Who can join the trial?

13 criteria

  • The participant must have completed the previous trial and be considered able to safely continue by the study doctor or sponsor.
  • The participant must weigh at least 17.0 kg (about 37.5 pounds) on the day they join the trial.
  • The participant's Body Mass Index (BMI) should be between the 5th and 120% of the 95th percentile, which is a way to measure if their weight is healthy for their height and age.
  • The participant must be between 6 and 17 years old.
  • Written permission must be given by the participant's parent or legal guardian, and the participant must agree to join the study. In some places, participants aged 15 to 17 can give their own permission, but their parents or guardians must be informed.
  • The participant or their caregiver must have used an electronic headache diary correctly, recording headache information on at least 21 out of 28 days before the trial starts.
  • Girls who have started their periods or are 12 years or older must have a negative pregnancy test before starting the trial or be unable to become pregnant.
  • Girls who have started their periods or are 12 years or older and are sexually active must use effective birth control during the trial and for 6 months after. Boys who are sexually active must use a condom during the trial and for 6 months after.
  • The participant must have received all recommended vaccines for their age according to local guidelines.
  • The participant must be in good health based on medical history, physical examination, heart test (ECG), and various lab tests.
  • The participant and their caregiver must be willing and able to follow the trial rules, stay at the clinic as needed, and return for follow-up visits.
  • The participant should not be using more than two preventive medications for migraines or other conditions, and any medication they are using should have been stable for at least 2 months before starting the trial.
  • The participant can continue using a stable dose of any preventive medication they were taking during the previous trial.

Who cannot join the trial?

9 criteria

  • Participants who are not between the ages of 6 to 17 years old.
  • Participants who do not have a diagnosis of either episodic or chronic migraine. Episodic migraine means having headaches on fewer days, while chronic migraine means having headaches on more days.
  • Participants who have any other medical condition that might interfere with the study.
  • Participants who are unable to follow the study procedures or instructions.
  • Participants who are currently participating in another clinical trial.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who are pregnant or breastfeeding.
  • Participants who have any known allergies to the study medication.
  • Participants who have any serious health conditions that could affect their safety during the study.
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Investigated drugs

Fremanezumab is a medication used in this clinical trial to help prevent migraines in children and teenagers aged 6 to 17. It is given as a monthly injection under the skin. The study aims to see how safe and well-tolerated this medication is when used over a long period. The goal is to reduce the frequency and severity of migraine attacks in young patients.

What is already known about the treatment

Fremanezumab – This medication is administered through a subcutaneous injection, typically given once a month. It is currently being studied in clinical trials for its long-term safety and effectiveness in preventing migraines, specifically in children and teenagers aged 6 to 17. Fremanezumab is primarily used for treating both episodic and chronic migraines. It works by targeting and blocking a protein called calcitonin gene-related peptide (CGRP), which is involved in the development of migraine headaches. This medication is classified as a monoclonal antibody, which is a type of biological therapy.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. It can be classified into episodic and chronic forms, with episodic migraines occurring less frequently and chronic migraines happening on 15 or more days per month. The progression of a migraine attack typically involves four stages: prodrome, aura, headache, and postdrome, though not everyone experiences all stages. During the prodrome phase, individuals may notice subtle changes such as mood swings or food cravings. The aura phase can involve visual disturbances or other sensory changes. The headache phase is marked by severe pain, usually on one side of the head, and the postdrome phase may leave individuals feeling drained or confused.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512837-34-00Protocol codeTV48125-CNS-30084Estimated enrolment505 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

sourced from the EU Clinical Trials Register and site verification

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