Topiramate in migraine prophylaxis in children and adolescents
There are currently no drugs approved by FDA -The United States Food and Drug Administration for migraine prophylaxis in children. In the UK Topiramate is licensed for those over 16 years, under the supervision of a specialist.
Topiramate has FDA approval for use in adults for migraine prophylaxis. There is very little data from randomized controlled trials on the safety and efficacy of topiramate in migraine prophylaxis in children.
A recent Randomized, Double-Blind, Placebo-Controlled Study was done on Adolescents (12-17 years of age) with a 6-month history of migraine who were assigned randomly to receive 16 weeks of daily treatment with topiramate (50 or 100 mg/day) or placebo. The study showed that the 100 mg/day topiramate group demonstrated efficacy in the prevention of migraine in pediatric subjects. Topiramate treatment was overall safe and well tolerated.(Pediatrics. 2009 Mar;123(3):924-34)
Another Class I Randomized double-blind placebo-controlled trial[1] on 131 children (6-15 years)used topiramate at 15mg/day, titrated over 8 weeks to 2-3mg/kg/day, and maintained for 12 weeks. There was a reduction of 2.6 migraine days per month, compared with a mean reduction of 2 migraine days per month in the placebo group.
Rapoport et al 2006 in a big Open-Label Extension of Pivotal Trials on 403 children agaed 12-18 yrs showed a sustained reduction in migraine frequency for upto 14 months in patients receiving topiramate
Ferraro et al 2008[2] in a recent review of 5 studies including 2 Class I RCTs and 3 other Class IV studies suggested that topiramate at a dose of 2-3mg/kg/day is effective in the preventive treatment of pediatric migraine. These dosages are much lower than those indicated for the adjunctive treatment of epilepsy (5–9 mg/kg/day) in children as young as 2 yrs.
Since they reduce cortical hyperexcitability antiepileptic drugs including topiramate do represent an interesting therapeutic option in migraine
However further controlled studies are needed to confirm these suggestions
| Drug[3] | Suggested dosage regime | Side effects | Rationale |
| Topiramate | Over 16 years 25 mg at night increasing to 50 mg twice daily as required | Reduced appetite, weight loss, gastrointestinal, headache, impaired memory and concentration | BNF-C –Adult BNF +++Licensed 16 years Controlled trials + |
- Winner P, Pearlman EM, Linder SL, Jordan DM, Fisher AC, and Hulihan J. Topiramate for migraine prevention in children: a randomized, double-blind, placebo-controlled trial. Headache 2005 Nov-Dec; 45(10) 1304-12. doi:10.1111/j.1526-4610.2005.00262.x pmid:16324162.
- Ferraro D, Di Trapani G (2008). "Topiramate in the prevention of pediatric migraine: literature review.". J Headache Pain 9 (3): 147-50. doi:. PMID 18385933. PMC PMC2386848. http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=clinical.uthscsa.edu/cite&email=badgett@uthscdsa.edu&retmode=ref&cmd=prlinks&id=18385933.
- Archives of Disease in Childhood - Education and Practice 2007;92:ep50-ep55
