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Study on Galcanezumab for Preventing Chronic Migraine in Adolescents Aged 12 to 17

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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 Chronic Migraine in adolescents aged 12 to 17. The treatment being tested is called Galcanezumab, which is a solution for injection. The study aims to determine if Galcanezumab is more effective than a placebo in preventing migraines in this age group.

Participants in the study will receive either Galcanezumab or a placebo. The study will monitor changes in the number of migraine headache days over a period of three months. The goal is to see if there is a reduction in the frequency of migraines for those receiving the treatment compared to those receiving the placebo.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased and reliable. The trial is expected to continue until 2026, providing valuable information on the effectiveness of Galcanezumab in managing Chronic Migraine in adolescents.

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

    Joining the study

    Upon joining the study, the participant is confirmed to have a diagnosis of chronic migraine, characterized by headaches occurring on 15 or more days per month for at least the last 3 months, with migraine features on at least 8 days per month.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either galcanezumab or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.

  3. Step 3

    Treatment phase

    Participants receive galcanezumab as a solution for injection. The specific dosage and frequency are determined by the study protocol, which aims to assess the medication's effectiveness in preventing migraines.

    The treatment phase lasts for a period of 3 months, during which the number of monthly migraine headache days is monitored and recorded.

  4. Step 4

    Evaluation

    The primary goal is to observe any change from baseline in the number of monthly migraine headache days over the 3-month period.

    Participants' progress is evaluated to determine the effectiveness of galcanezumab compared to the placebo.

  5. Step 5

    Study completion

    The study is estimated to conclude by March 30, 2026. Participants will have completed their involvement in the trial by this date, and the data collected will contribute to the study's findings.

Who can join the trial?

3 criteria

  • The patient must be between 12 and 17 years old.
  • The patient must have a diagnosis of chronic migraine. This means having headaches on 15 or more days each month for at least the last 3 months, with at least 8 of those days having features of a migraine headache.
  • Both male and female patients can participate.

Who cannot join the trial?

9 criteria

  • Patients who are not between the ages of 12 to 17 years old.
  • Patients who do not have chronic migraine. A chronic migraine is a type of headache that occurs frequently, often more than 15 days a month.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are taking medications that could affect the study results.
  • Patients who have participated in another clinical trial recently.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a known allergy to the study medication.
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Investigated drugs

Galcanezumab is a medication being studied for its ability to prevent migraines in adolescents aged 12 to 17 who suffer from chronic migraines. It is designed to reduce the frequency and severity of migraine attacks by targeting specific pathways in the brain associated with migraine development.

What is already known about the treatment

Galcanezumab – This medication is administered via injection and is used to prevent chronic migraines. It is currently being studied in clinical trials, specifically in adolescents aged 12 to 17, to assess its effectiveness compared to a placebo. Galcanezumab works by targeting and blocking a protein called calcitonin gene-related peptide (CGRP), which is involved in the development of migraine headaches. It belongs to the pharmacological class of monoclonal antibodies.

Investigated diseases

Chronic Migraine – Chronic migraine is a neurological condition characterized by experiencing headaches on 15 or more days per month, with at least 8 of those days involving migraine features. These features can include throbbing pain, sensitivity to light and sound, nausea, and sometimes aura, which are visual or sensory disturbances. The condition often begins with episodic migraines that increase in frequency over time. It can significantly impact daily activities and quality of life due to the frequent and severe nature of the headaches. The progression of chronic migraine can vary, with some individuals experiencing periods of improvement or worsening. Understanding the triggers and patterns of these headaches is crucial for managing the condition effectively.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-505835-11-00Protocol codeI5Q-MC-CGATEstimated enrolment302 patientsSponsorEli Lilly & Co.

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