Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study

• Register: JPRN
• Last refreshed on: 26 April 2013
• Main ID: JPRN-UMIN000003490
• Date of registration: 15/04/2010
• Primary sponsor: School of pharmacy, Kitasato university
• Public title: Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study
• Date of first enrolment: 2010/02/01
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.umin.ac.jp/ctr/index.htm
• Study type: Interventional
• Study design: Cross-over Randomized

Countries of recruitment

Japan

Contacts

• Name: Kensuke Usui
• Affiliation: School of pharmacy, Kitasato university Pharmacy practice and science Department of clinical pharmacy Center for clinical pharmacy and clinical sciences

• Name: Kensuke Usui
• Affiliation: School of pharmacy,Kitasato university Pharmacy practice and science Department of clinical pharmacy Center for clinical pharmacy and clini

Key inclusion & exclusion criteria

Inclusion criteria: 1)Patients who are diagnosed with migraine according to the International Classification of Headache Disorders 2nd Edition(ICHD-II)
2)Patients who occur attacks of migraine 2 times or more per month
3)Triptan-naive patients or patients who don't determined a preference for triptans
4)Onset of migraine before the age of 50 years
5)Patients between 18 and 65 years of age
6)Both male and female patient
7)Patients who are provided informed,written consent for participation
Exclusion criteria: 1)Patients with headache which is inability to distinguish between migraine and nonmigraine
2)Female who are pregnant or may be pregnant
3)Lactation
4)Patients with renal or hepatic impairment
5)Patients with history of myocardial infarction or with symptoms of ischemic heart disease
6)Patients with peripheral vascular disease
7)Patients with history of epileptiform attack or with brain disorder
8)Patients on monoamine oxidase inhibitors or within 2 weeks of discontinuation of monoamine oxidase inhibitors
9)Patients on HIV protease inhibitors
10)Hemodialysis patients
11)Patients on propranolol
12)Uncontrolled hypertension patients
13)Patients with psychiatric disorder which affect participation
14)Patients with hypersensitivity to any component of the study medications

Age minimum: 18years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

migraine

Intervention(s)

1.Sumatriptan succinate 50mg
2.Eletriptan hydrobronide 20mg
3.Naratriptan hydrochloride 2.5mg
4.Zolmitriptan 2.5mg
5.Rizatriptan benzoate 10mg
Duration of treatment periods:8 weeks per a treatment,total 40weeks
1.Eletriptan hydrobronide 20mg
2.Sumatriptan succinate 50mg
3.Naratriptan hydrochloride 2.5mg
4.Rizatriptan benzoate 10mg
5.Zolmitriptan 2.5mg
Duration of treatment periods:8weeks per a treatment,total 40weeks
1.Naratriptan hydrochloride 2.5mg
2.Eletriptan hydrobronide 20mg
3.Sumatriptan succinate 50mg
4.Zolmitriptan 2.5mg
5.Rizatriptan benzoate 10mg
Duration of treatment periods:8weeks per a treatment,total 40weeks

Primary Outcome(s)

#intensity of headache at 1 hour after taking the medication
#intensity of headache at 2 hours after taking the medication
#presence or absence of recurrence of migraine from 2 through 24 hours after taking the medication

Secondary Outcome(s)

#frequency of attacks
#consumption of triptans per 8 weeks
#consumption of nonsteroidal antiinflammatory drugs(NSAIDs) and other analgestics
#HIT-6 scores

Source(s) of Monetary Support

None

Secondary Sponsor(s)

Kitasato Institute Hospital headache center