Paediatric migraine Nervous System Diseases Migraine
Conditions
Interventions
Eligible participants will be randomly allocated to the following four arms after the 4-week run-in period, double blind:
Arm 1 (n = 200): Propranolol (oral
tablet or liquid):
Children aged 5 - 7:
Week 1: 10 mg twice daily (bd)
Week 2: 20 mg bd
Week 3 - 14: 30 mg bd
Children aged 8 - 11:
Week 1: 20 mg bd
Week 2: 30 mg bd
Week 3 - 14: 40 mg bd
Children
tablet or liquid):
Children aged 5 - 7:
Week 1: placebo + pizotifen 500 µg once daily (od)
Week 2: placebo + pizotifen 1 mg od
Week 3 - 14: placebo + pizotifen 1.5 mg od
Children aged 8 - 11:
Week 1
Sponsors
University of Nottingham (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both males and females, age 5 years 0 months to 16 years 11 months 2. With Migraine with Out aura (MO), Migraine with Aura (MA), Probable Migraine (PM) as defined by the International Headache Society (IHS1) criteria, with 2 to 6 migraine or probable migraine attacks/ 4 weeks by history during the previous 3 months 3. Two to 6 migraine or probable migraine attacks/ 4 weeks during the 4 week run-in 4. Treating paediatrician and parent/ guardian and child or young person believe the attacks are currently frequent and severe enough to merit a try of twice daily preventative medication 5. Satisfactory completion of headache diary during the run-in period at discretion of the investigator
Exclusion criteria
Exclusion criteria: Amended as of 13/07/2009: 1. Asthma, bronchospasm or nocturnal or exercise induced cough or wheeze within the last 12 months or currently on daily asthma preventative treatment 2. Children under paediatric cardiology review, at the discretion of their paediatric cardiologist, e.g. if propranolol or pizotifen were contraindicated 3. Children with any of the following: uncontrolled heart disease, the presence of second or third degree heart block, in cardiogenic shock, bradycardia, severe peripheral arterial disease, metabolic acidosis, sick sinu syndrome, untreated phaeochromocytoma, prone to hypoglycaemia (e.g. after prolonged fasting) or Prinzmetal's angina 4. Previous severe adverse event probably related to propranolol or pizotifen 5. On propranolol, another beta-blocker, pizotifen or cyproheptidine in the last 3 months 6. Currently in or have been in another prospective drug trial in the last 3 months 7. Fewer than two or more than six eligible attacks during the 4 week run-in, and stay excluded for 3 months at least 8. Child or family unable to identify their migraine or probable migraine headaches confidently (as may happen with some patients with both mild headaches and migraine on different days, e.g. with chronic daily headache [15 or more headache days/month]) 9. Females of child bearing potential who are not using a reliable contraceptive strategy such as abstinence, barrier methods, oral contraceptive pills and contraceptive injections 10. Informed consent not given by parents/guardian, or assent/consent not given by patient Initial information at time of registration: 1. Asthma or nocturnal or exercise induced cough or wheeze within the last 12 months or currently on daily asthma preventative treatment 2. Children under paediatric cardiology review, at the discretion of their paediatric cardiologist, e.g., if propranolol or pizotifen were contraindicated 3. Previous severe adverse event probably related to propranolol or pizotifen 4. On propranolol, another beta-blocker, pizotifen or cyproheptidine in the last 3 months 5. Currently in or have been in another prospective drug trial in the last 3 months 6. Fewer than 2 or more than 6 eligible attacks during the 4 week run-in, and stay excluded for 3 months at least 7. Child or family unable to identify their migraine or probable migraine headaches confidently (as may happen with some patients with both mild headaches and migraine on different days, e.g., with chronic daily headache [15 or more headache days/month]) 8. Females of child bearing potential who are not using a reliable contraceptive strategy such as abstinence, barrier methods, oral contraceptive pills and contraceptive injections 9. Informed consent not given by parents/guardian, or assent/consent not given by patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of migraine attacks during weeks 11 to 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response defined as a 50% or greater reduction in number of attacks. Duration of follow-up: 42 weeks. 2. Headache intensity (headache diary). Duration of follow-up: 14 weeks. 3. Use of rescue medication. Duration of follow-up: 14 weeks. 4. School attendance. Duration of follow-up: 14 weeks. 5. Parent/guardian time off work during weeks 11 to 14 6. Recalled attack frequency. Duration of follow-up: 14 weeks. 7. Quality of life and functional outcomes: Paediatric Migraine Disability Assessment (PedMIDAS), Generic Child Quality of Life measure (GCQ), parent Euroqol EQ-5D, child Euroqol EQ-5D | — |
Countries
United Kingdom
Outcome results
None listed