Preventing migraine in children and young people
| ISRCTN | ISRCTN97360154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97360154 |
| Secondary identifying numbers | HTA 05/15/01; 29372 |
- Submission date
- 25/09/2008
- Registration date
- 07/10/2008
- Last edited
- 11/01/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr William Whitehouse
Scientific
Scientific
University of Nottingham
E Floor East Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 ext 63328 |
|---|---|
| william.whitehouse@nottingham.ac.uk |
Study information
| Study design | Parallel-group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A double-blind parallel-group randomised placebo-controlled trial of propranolol and pizotifen in preventing migraine in children |
| Study acronym | P3MC |
| Study objectives | 1. Propranolol is superior to placebo for the prevention of migraine attacks in children aged 5 - 16 years 2. Pizotifen is superior to placebo for the prevention of migraine attacks in children aged 5 - 16 years More details can be found at http://www.hta.ac.uk/1526 Protocol can be found at http://www.hta.ac.uk/protocols/200500150001.pdf |
| Ethics approval(s) | Trent Research Ethics Committee (REC) approved in November 2008 (ref: 09/H0405/19) |
| Health condition(s) or problem(s) studied | Paediatric migraine |
| Intervention | 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 aged 12 - 16: Week 1: 30 mg bd Week 2: 40 mg bd Week 3 - 14: 60 mg bd Week 15 - 16: Dose of the drug will be reduced gradually before stopping completely Arm 2 (n = 200): Pizotifen (oral; 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: placebo + pizotifen 1 mg od Week 2: placebo + pizotifen 1.5 mg od Week 3 - 14: placebo + pizotifen 2 mg od Children aged 12 - 16: Week 1: placebo + pizotifen 1.5 mg od Week 2: placebo + pizotifen 2 mg od Week 3 - 14: placebo + pizotifen 3 mg od Week 15 - 16: Dose of the drug will be reduced gradually before stopping completely Arm 3 (n = 100): Propranolol placebo control group Arm 4 (n = 100): Pizotifen placebo control group Amended as of 11/01/2012, the trial was stopped early due to poor recruitment at the end of June 2011. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propranolol, pizotifen |
| Primary outcome measure | Number of migraine attacks during weeks 11 to 14 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2009 |
| Completion date | 01/07/2012 |
| Reason abandoned (if study stopped) | "Participant recruitment issue" |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target number of participants | 600 (Poor recruitment, study stopped at the end of June 2011) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/06/2010 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
