Long Term Safety and Tolerability of Rizatriptan in Paediatrics

• Research type

  Research Study

• Full title

  A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Paediatric Migraineurs for the Treatment of Migraine With or Without Aura

• IRAS ID

  36647

• Contact name

  Jayaprakash Gosalakkal

• Sponsor organisation

  Merck & Co., Inc.

• Eudract number

  2009-016375-30

• 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 under18 years. The sponsor, Merck & Co., Inc., is conducting a study to investigate safety and tolerability of rizatriptan (the study drug) in the long term treatment of acute migraine in participants aged 12-17 years. The study will also investigate the efficacy of the study drug. Using a weight-based dosing strategy, participants weighing less than 40 kg will receive rizatriptan 5 mg and participants weighing greater than or equal to 40 kg will receive rizatriptan 10 mg. Participants in this study will take the study medication for about 12 months and will be required to visit the study site about 8 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 As the study is Ó?open label?, both the participant and the study doctor will know the study medication being taken by the participant and at what dose. Around 630 participants aged 12-17 years will be enrolled into the study worldwide.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/6

• Date of REC Opinion

  25 Mar 2010

• REC opinion

  Further Information Favourable Opinion