A preference trial with naratriptan 2.5 mg and paracetamol 1000 mg in migraine patients in the general practice

ISRCTN ISRCTN57387771
DOI https://doi.org/10.1186/ISRCTN57387771
Secondary identifying numbers NTR34
Submission date
16/05/2005
Registration date
16/05/2005
Last edited
02/04/2008
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 N.J. Wiendels
Scientific

Leiden University Medical Center (LUMC)
Department of Neurology, K5Q-106
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 526 1730
Email N.J.Wiendels@lumc.nl

Study information

Study designA randomised, double blind, double-dummy, cross-over study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTraditional 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedMigraine
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Naratriptan, paracetamol
Primary outcome measureDirection 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 measures1. Changes in quality of life
2. Pain free rate at 2 hours postdose
Overall study start date01/01/2005
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/01/2005
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre

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

Website http://www.lumc.nl/english/start_english.html
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Industry

GlaxoSmithKline (The Netherlands)
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom
Leiden University Medical Centre (LUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan