A preference trial with rizatriptan 10 mg and ibuprofen 400 mg in migraine patients in the general practice

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 35

Inclusion Criteria

1. At least 18 years of age at visit 1
2. Current history of migraine with or without aura according to the International Headache Society (IHS) criteria
3. Experienced an average of at least one migraine attack per month for six months prior to entry to the study
4. Naïve to the use of 5HT1 agonists and ergotamine
5. Willing and able to understand and complete questionnaires
6. Willing and able to give informed consent prior to entry into the study

Exclusion Criteria

1. 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. A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA)
3. A history of hypertension or a current blood pressure above 160/95 mmHg (measured three times)
4. A history of basilar, hemiplegic or ophtalmoplegic migraine
5. Impaired hepatic or renal function
6. A history of gastrointestinal disease
7. A history of asthma
8. Have a known or suspected hypersensitivity to, intolerance of, or contraindications to any component of the study medication
9. Currently use propanolol as a prophylactic agent
10. Currently use monoamine oxidase (MAO) inhibitors
11. Currently abuse alcohol, analgesics or psychotropic drugs
12. A history of hypertension
13. Any severe concurrent medical condition, which may affect the interpretation in a clinical trial
14. Females who are pregnant or breastfeeding, and females of childbearing potential who are not using a medically acceptable form of contraception
15. Have participated in a clinical trial within the previous month or are currently participating in any other clinical research study or clinical trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Direction and strength of patient preference on a 10 cm scale ranging from -5 (strong preference for treatment 1) to +5 (strong preference for treatment 2) where 0 indicates no preference.

Secondary Outcome Measures

Name	Time	Method
1. Pain free rate at 2 hours postdose<br>2. Migraine disability assessment (MIDAS) score at visit 1

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