PREvention of Migraine In Adolescents
| ISRCTN | ISRCTN33364178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33364178 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised, placebo controlled, parallel group, triple blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propanolol |
| Primary outcome measure | 1. Perceived effect and change of intensity 2. Frequence and duration of migraine attacks |
| Secondary outcome measures | 1. Change in 'quality of life'- experience 2. Number of schooldays missed 3. Medical consumption |
| Overall study start date | 01/10/2006 |
| 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 number of participants | 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
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Website | http://www.erasmusmc.nl/#http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Other
Nuts/Ohra (The Netherlands)
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 |
