Rizatriptan for the treatment of migraine in children and adolescents

  • Research type

    Research Study

  • Full title

    A Worldwide, Randomised, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents

  • IRAS ID

    33748

  • Contact name

    Jayaprakash Gosalakkal

  • Sponsor organisation

    Merck & Co., Inc.

  • Eudract number

    2009-016374-32

  • ISRCTN Number

    n/a

  • Clinicaltrials.gov Identifier

    n/a

  • Research summary

    Migraine is a common disorder affecting children, adolescents and adults. It is characterised by attacks of moderate or severe headaches and is commonly associated with symptoms including nausea, vomiting, photophobia, and/or phonophobia (extreme sensitivity to light or loud sounds respectively). Migraines contribute significantly to school absence, work loss, medication use, impaired quality of life, and health care visits. Rizatriptan is an approved treatment for migraines in adults however it is not yet approved for use in children and adolescents under 18 years. The sponsor, Merck & Co., Inc., is conducting a study to investigate the safety and effectiveness of rizatriptan compared to placebo (an inactive drug, sometimes call a sugar pill) in the treatment of acute migraine in participants aged 6 to 17 years. The study is randomized, double-blinded and placebo-controlled, meaning participants will be allocated at random to a treatment group. Each randomized participant will treat one qualifying migraine attack. Using a weight-based dosing strategy, participants weighing less than 40 kg will receive rizatriptan 5mg or matching placebo, and participants weighing greater than or equal to 40 kg will receive rizatriptan 10 mg or matching placebo. Participants will be required to visit the study site about 2 times. During the study the following tests and procedures will be conducted * Physical examination * Collection of blood and urine samples for safety testing * Electrocardiogram or ECG (a non-invasive test to measure the electrical activity of the heart) * Answer questions along with the participant's parent/guardian about their migraines * Completion of a migraine diary Participants will treat a single migraine attack in two stages. Stage 1 Participants will be randomised in a 20:1 ratio to placebo or study medication (rizatriptan). Participants will take the study medication within 30 minutes of onset of a migraine attack. After 15 minutes, participants will report their pain through a telephone system and those that report mild pain or no pain (i.e., responders) will not take any additional study medication. Stage 2 Participants who report moderate or severe pain will be instructed to take study medication and will be randomised in a 1:1 ratio to the study medication or placebo. Participants who received rizatriptan in Stage 1 will receive placebo in Stage 2. As the study is double blind, both the participant and the study doctor will not know the assigned treatment. Approximately 900 participants will be enrolled into the study worldwide.

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    10/H0408/5

  • Date of REC Opinion

    8 Mar 2010

  • REC opinion

    Further Information Favourable Opinion