PREvention of Migraine In Adolescents
| ISRCTN | ISRCTN33364178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33364178 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | Nuts/Ohra (The Netherlands) |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 29/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 D Noordzij
Scientific
Scientific
Erasmus Medical Centre
Department of General Practice
Westzeedijk 112-114
Alkmaar
3016 AH
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, triple blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PREMIA |
| Study objectives | Based on systematic reviews concerning effective treatments in children with migraine a medical treatment (propanolol) as well as a non-medical treatment (relaxation therapy) appear to be effective compared to no treatment or placebo. However their relative effectiveness is unknown. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | Group 1: Propanolol treatment and placebo relaxation treatment Group 2: Placebo medical treatment and relaxation therapy |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propanolol |
| Primary outcome measure(s) |
1. Perceived effect and change of intensity |
| Key secondary outcome measure(s) |
1. Change in 'quality of life'- experience |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Migraine patients 2. Aged 13 to 18 years 3. Living in Rotterdam |
| Key exclusion criteria | 1. Patients suffering from asthma, allergies and diabetes 2. Using propanolol and/or relaxation therapy as a treatment less then six months before the start of the trial |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Alkmaar
3016 AH
Netherlands
3016 AH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
