Condition category
Nervous System Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
29/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Noordzij

ORCID ID

Contact details

Erasmus Medical Centre
Department of General Practice
Westzeedijk 112-114
Alkmaar
3016 AH
Netherlands

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

http://www.erasmusmc.nl/#http://www.erasmusmc.nl/

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

Publication citations

Additional files

Editorial Notes