Condition category
Nervous System Diseases
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
02/04/2008
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 N.J. Wiendels

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Neurology
K5Q-106
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 1730
N.J.Wiendels@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR34

Study information

Scientific title

Acronym

Study hypothesis

Traditional efficacy outcome measures in migraine trials are not sensitive enough to detect clinically relevant differences between two active agents. A promising novel method of comparing migraine treatments is a patient preference study, in which the patients are asked to use both treatments and then assign preference to one of the treatments. We would like to test the concept of patient preference as the primary endpoint in a randomised double blind cross-over study, comparing an analgesic with a triptan for the acute treatment of three migraine attacks in patients from the general population, who have not used a triptan or ergot before.

Hypothesis:
Patients prefer naratriptan over paracetamol 1000 mg for the acute treatment of migraine attacks.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

A randomised, double blind, double-dummy, cross-over study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Migraine

Intervention

1. Naratriptan 2.5 mg
2. Paracetamol 1000 mg

Subjects will be randomised to either naratriptan or paracetamol with a cross-over after three attacks. Subjects rate their satisfaction with treatment after each attack. Preference is evaluated after the second treatment period.

Intervention type

Drug

Phase

Not Specified

Drug names

Naratriptan, paracetamol

Primary outcome measures

Direction and strength of patient preference on a 10 cm scale ranging from -5 (strong preference for treatment A) to +5 (strong preference for treatment B), where 0 indicates no preference.

Secondary outcome measures

1. Changes in quality of life
2. Pain free rate at 2 hours postdose

Overall trial start date

01/01/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. The subject is greater than or equal to 18 years of age at visit 1
2. The subject has a current history of migraine with or without aura according to the International Headache Society (IHS) criteria
3. The subject has experienced an average of at least one migraine day per month for six months prior to entry to the study
4. The subject is naïve to the use of 5HT1 agonists and ergotamine
5. The subject is willing and able to understand and complete questionnaires
6. The subject is willing and able to give informed consent prior to entry into the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Subjects with a history suggestive of ischaemic heart disease (IHD) (e.g. angina pectoris) or any atherosclerotic disease which places them at increased risk of coronary ischaemia
2. Subjects with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA)
3. Subjects who currently abuse alcohol, analgesics or psychotropic drugs
4. Subjects who have any severe concurrent medical condition which may affect the interpretation in a clinical trial
5. Subjects with a history of basilar, hemiplegic or ophtalmoplegic migraine
6. Subjects with impaired hepatic or renal function
7. Subjects who have a known or suspected hypersensitivity to, intolerance of, or contra-indications to any component of the study medication
8. Females who are pregnant or breastfeeding, and females of childbearing potential who are not using a medically acceptable form of contraception
9. Subjects who have participated in a clinical trial within the previous month or are currently participating in any other clinical research study or clinical trial
10. Subjects with a history of hypertension or a current blood pressure above 160/95 mmHg(measured three times)

Recruitment start date

01/01/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Neurology
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (The Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Leiden University Medical Centre (LUMC) (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