None listed
Conditions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject is at least 18 years of age at visit 1; 2. The subject has a current history of migraine with or without aura according to the IHS criteria; 3. The subject has experienced an average of at least one migraine attack per month for 6 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.
Exclusion criteria
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 with a history of hypertension or a current blood pressure above 160/95 (measured 3 times); 4. Subjects with a history of basilar, hemiplegic or ophtalmoplegic migraine; 5. Subjects with impaired hepatic or renal function; 6. Subjects with a history of gastrointestinal disease; 7. Subjects with a history of asthma; 8. Subjects who have a known or suspected hypersensitivity to, intolerance of, or contraindications to any component of the study medication; 9. Subjects who currently use propanolol as a prophylactic agent; 10. Subjects who currently use MAO-inhibitors; 11. Subjects who currently abuse alcohol, analgesics or psychotropic drugs; 12. Subjects with a history of hypertension; 13. Subjects who have 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Painfree rate at 2 hours postdose; 2. MIDAS score at visit 1. | — |
Contacts
Public ContactN.J. Wiendels
Leiden University Medical Center (LUMC), Department of Neurology, K5Q-93, P.O. Box 9600
Outcome results
None listed