Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PREMIA
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, triple blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Propanolol
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Migraine patients
2. Aged 13 to 18 years
3. Living in Rotterdam
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
160
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
31/07/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Alkmaar
3016 AH
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Nuts/Ohra (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary