Testing new medicine for children’s migraine relief

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    What is this study about?

    This study is a test to see how safe and effective a medicine called Atogepant is when given to children and teenagers (6 to 17 years old) who get migraines. Migraines are bad headaches that can make feel sick or sensitive to light and sound. Atogepant is a tablet that is already approved for adults who get migraines, and now the researchers want to see how it works for younger people. The patients will be divided into six groups, which will be given either a placebo, a low-dose Atogepant, or a high-dose Atogepant. This will continue for 12 weeks. After this, there may be further follow-up visits or another study where the patients can continue to take the Atogepant. Testing during the study will include doctor’s visits, blood tests, questionnaires and checking for any side effects.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Herlev , Denmark

      Herning , Denmark

      Aalborg , Denmark

      Creteil , France

      Budapest , Hungary

      Budapest , Hungary

      Milan , Italy

      Palermo , Italy

      Den Haag , Netherlands

      Terneuzen , Netherlands

      Lublin , Poland

      Krakow , Poland

      Warszawa , Poland

      Poznan , Poland

      Bydgoszcz , Poland

      Wroclaw , Poland

      Barcelona , Spain

      Madrid , Spain

      Sevilla , Spain

      Valencia , Spain

      Molnlycke , Sweden

      Aberdeen , United Kingdom

      You can join this study in:

      Denmark: Aalborg, Herlev, Herning.

      United Kingdom: Aberdeen.

      Spain: Barcelona, Madrid.

      Hungary: Budapest.

      Poland: Bydgoszcz, Lublin, Poznań, Wrocław.

      France: Créteil.

      Italy: Milan, Palermo.

      Sweden: Mölnlycke.

      Netherlands: Terneuzen.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      As a patient in this clinical trial, the steps you would need to take include:

      1. Undergo randomization to be placed into one of 6 different groups.
      2. If you are between the ages of 12 and 17, you could be randomized to receive either a placebo, a low-dose atogepant, or a high-dose atogepant for a period of 12 weeks.
      3. If you are between the ages of 6 and 11, similar randomization will take place to receive a placebo or an atogepant dose (low or high) for 12 weeks as well, with the specific doses determined after a PK substudy is complete.
      4. Take the allocated treatment (placebo or atogepant) in the form of an oral tablet once a day.
      5. Attend regular visits at a hospital or clinic throughout the study duration for:
        • Medical assessments
        • Blood tests
        • Monitoring for side effects
        • Completing questionnaires to assess the effects of the treatment
      6. At the conclusion of Week 12, go through a follow-up visit 4 weeks after the last dose of study treatment, or choose to participate in an extension study where you may continue to receive atogepant for an additional 52 weeks.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a history of episodic migraine with or without aura, consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018), for at least 6 months.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study along with explanations for medical terms where necessary:

      Inclusion Criteria:

      1. Weight: Your weight should be greater than or equal to 20 kg (44 lbs) and less than 135 kg (298 lbs).
      2. History of episodic migraine: You should have a history of episodic migraine, with or without aura, that is consistent with the diagnosis criteria according to the International Classification of Headache Disorders, 3rd edition (ICHD-3, 2018), for at least 6 months.
        • Episodic migraine: This is a type of migraine that occurs on fewer than 15 days per month.
        • Aura: Sensory disturbances that can include visual changes (like seeing zigzag patterns or flashes), sensory symptoms (such as tingling in the face or hands), or speech difficulty, usually occurring before the headache phase.
        • ICHD-3: This is a comprehensive classification system for headache disorders updated by the International Headache Society in 2018.
      3. Migraine frequency: You need to have experienced 4 to 14 days with migraine and fewer than 15 headache days in total within the 28-day baseline period, as recorded in an electronic diary (eDiary).
      4. Pharmacokinetics (PK) substudy: To participate in the PK substudy, participants must be between 6 to 11 years old and judged by the study investigator as appropriate to receive preventive treatment for migraine. The PK substudy likely assesses how the body absorbs, distributes, metabolizes, and excretes the study drug.
        • Pharmacokinetics (PK): This field of study deals with how drugs move through and are processed by the body over time.

      Please note that these criteria do not include any exclusion criteria for the study.

      What Reasons Could Exclude Me from the Study?

      Here is a list of exclusion criteria with explanations of medical terms:

      1. History of migraine brainstem aura: This type of migraine involves visual, auditory or other sensory disturbances that originate from the brainstem, but do not include motor weakness.
      2. Hemiplegic migraine: A rare form of migraine where there is a temporary weakness on one side of the body (hemiplegia) as part of the aura.
      3. Retinal migraine: Migraines that involve temporary, partial, or complete loss of vision in one eye, along with a dull ache behind the eye that may spread to the rest of the head.
      4. Current diagnosis of chronic migraine: This is when headaches occur on 15 or more days a month for more than three months, which has the features of migraine headache on at least 8 days a month.
      5. Current diagnosis of new persistent daily headache: A headache that begins abruptly and occurs daily from its onset, which is persistent, often resistant to therapies.
      6. Trigeminal autonomic cephalalgias (e.g., cluster headache): A category of headache disorders involving the trigeminal nerve and autonomic nervous system, causing severe headaches on one side of the head.
      7. Painful cranial neuropathy: Disorders affecting the cranial nerves that can cause pain, such as in the case of trigeminal neuralgia.
      8. In-hospital treatment for migraine 3 or more times in the 6 months prior to Visit 1: This includes any hospital admissions to treat migraines, but does not include visits to the emergency department.

      Please let me know if you need more information on any of these criteria.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The active substance involved in the study is atogepant. This substance is known by the trade name Qulipta, with an alternative identifier AGN-241689.

      Here is a brief description of atogepant:

      1. Atogepant: It is a medicine approved for the treatment of adults with episodic migraine, which is characterized by having 0 to 14 migraine days per month. The drug is currently undergoing a Phase 3 clinical trial to evaluate its safety and efficacy in pediatric participants aged between 6 and 17 years with a history of episodic migraine. Atogepant is administered as oral tablets in either a low-dose or high-dose form to study participants for a period of 12 weeks. The exact doses for participants aged 6 to 11 will be determined after a pharmacokinetic substudy.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves the following active substances:

      1. Atogepant

        Description: Atogepant is an orally administered medication. It is currently approved to treat adults with episodic migraine, which includes 0 to 14 migraine days per month. In this study, it is being evaluated in pediatric participants aged 6 to 17 years with a history of episodic migraine. The medication is given as a tablet to take by mouth once a day at different dosages, with the study exploring both a low-dose and a high-dose regimen. Atogepant is known in the medical literature and has previously been studied and approved for use in adults under the name QULIPTA and has the research identifier AGN-241689.

      2. Placebo-Matching Atogepant

        Description: A placebo-matching atogepant is a tablet that is designed to look identical to the atogepant tablet but does not contain the active drug. Placebos are commonly used in clinical trials to evaluate the efficacy of the active drug by comparing its effects to those of an inert substance.


      Study ID

      CT-EU-00084810

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases