Condition category
Signs and Symptoms
Date applied
08/12/2016
Date assigned
15/12/2016
Last edited
02/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A migraine is a type of headache disorder which involves suffering from recurrent headaches that are moderate to severe. These headaches are usually felt as a throbbing pain on one side of the head and can be coupled with visual disturbances and nausea. The exact cause of migraines are unknown, however many believe it is related to histamine, a chemical produced by the immune system cells which help the body to get rid of something that is triggering an allergy. The breakdown of histamine involved different processes, including use of the enzyme diamine-oxidase (DAO). Low activity of DAO is related to the build-up of histamine in the body, which could cause migraines. The aim of this study is to find out whether treatment with DAO is an effective treatment for migraines.

Who can participate?
Adults who have suffered between four and fourteen migraines a month for at least six months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with DAO 20 minutes before breakfast, lunch and dinner for a total of one month. Those in the second group are treated with a placebo (dummy drug) 20 minutes before breakfast, lunch and dinner for a total of one month. Throughout the treatment period and for a further month, participants in both groups keep diaries recording the number of migraine attacks, duration of the attacks, intensity and treatment used.

What are the possible benefits and risks of participating?
There are no known benefits or risks involved with participating.

Where is the study run from?
Hospital General de Catalunya (Spain)

When is the study starting and how long is it expected to run for?
February 2011 to January 2013

Who is funding the study?
DR Healthcare (Spain)

Who is the main contact?
Dr Joan Izquierdo
jizquierdo@hgc.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joan Izquierdo

ORCID ID

Contact details

Hospital General de Catalunya
Calle Pedro i Pons
1
Sant Cugat del Valles
080195
Spain
+34 606 416 148
jizquierdo@hgc.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MigraDAO 002

Study information

Scientific title

Double blinded trial, comparative and controlled with placebo, to evaluate the efficiency of supplementation with diamino-oxidase versus placebo in the prophylactic treatment of migraine

Acronym

Study hypothesis

Patients with migraine have a low activity of diamino-oxidase, and enzymatic supplementation could improve the symptoms.

Ethics approval

Ethics Committee of the Hospital General de Catalunya, 10/08/2011, ref: V.1.1julio2011 MIGRADAO-002

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients with migraine and deficit in the activity of the Diamine-oxidase.

Intervention

Participants are randomised to one of two groups using the RANUNI procedure (SAS v. 6.12, SAS Institute, Cary, NC, USA).

Group 1: Participants are treated with 14mg diamine-oxidase 20 minutes before breakfast, lunch and dinner for one month

Group 2: Participants are treated with a placebo 20 minutes before breakfast, lunch and dinner for one month

Participants in both groups are followed up for for one month after the treatment period. During this time, participants record the number of migraine attacks, duration of the attacks, intensity and treatment used.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Hours of headache per month are measured using patient diaries at baseline and after 4 weeks of observation and after 4 weeks of treatment
2. Number of migraine crisis during the month are measured using patient diaries at baseline and after 4 weeks of treatment

Secondary outcome measures

1. Intensity of pain measured using a visual analogue scale at baseline and after 4 weeks of treatment
2. Number and type of analgesic used during the month is measured using patient diaries baseline and after 4 weeks of treatment

Overall trial start date

01/02/2011

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18 and 65 years old
2. 4-14 migraine episodes per month for a minimum of six months prior to study initiation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Beginning of migraines when participant was over 50 years old
2. Other kind of headaches diagnosed in the same patient
3. Possibility of pregnancy
4. Preventive treatment for episodic migraine during three months prior the study

Recruitment start date

01/08/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital General de Catalunya
Pedro i Pons 1
Sant Cugat del Valles (Barcelona)
08190
Spain

Sponsor information

Organisation

DR Healthcare

Sponsor details

Escoles Pies 29
Barcelona
08017
Spain
+34 935 533 692
jjduelo@dr-healthcare.com

Sponsor type

Industry

Website

www.dr-healthcare.com

Funders

Funder type

Industry

Funder name

DR Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Primary results were accepted and presented as an oral communication in the World Neurological Congress in Wien 2013. Planned publication in a high level impact publication in the field of nutrition.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mari Luz Latorre (mariluzlatorreb.edu)

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2018 publication results in: https://www.ncbi.nlm.nih.gov/pubmed/29475774

Publication citations

Additional files

Editorial Notes

02/03/2018: Publication reference added.