P3MC: a double blind parallel group randomised placebo controlled trial of
Propranolol and Pizotifen in preventing migraine in children.
Author(s): Silcocks P, Whitham D, Whitehouse WP.
Affiliation(s): University of Nottingham, E Floor East Block, Queen's Medical Centre, Nottingham,
NG7 2UH, UK.
Publication date & source: 2010, Trials. , 11:71
BACKGROUND: A recent Cochrane Review demonstrated the remarkable lack of reliable
clinical trials of migraine treatments for children, especially for the two most
prescribed preventative treatments in the UK, Propranolol and Pizotifen.Migraine
trials in both children and adults have high placebo responder rates, e.g. of
23%, but for a trial's results to be generalisable "placebo responders" should
not be excluded and for a drug to be worthwhile it should be clearly superior,
both clinically and statistically, to placebo.
METHODS/DESIGN: Two multicentre, two arm double blind parallel group randomised
controlled trials, with allocation ratio of 2:1 for each comparison, Propranolol
versus placebo and Pizotifen versus placebo. The trial is designed to test
whether Propranolol is superior to placebo and whether Pizotifen is superior to
placebo for the prevention of migraine attacks in children aged 5-16 years
referred to secondary care out-patient settings with frequent migraine (2-6/4
weeks). The primary outcome measure is the number of migraine attacks during
trial weeks 11 to 14.
DISCUSSION: A strength of this trial is the participation of clinically well
defined migraine patients who will also be approached to help with future
longer-term follow-up studies.
TRIAL REGISTRATION: ISRCTN97360154.