Clinical trial NCT01276977: Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Official title: Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Migraine
Migraine Headache
Headache Disorders
Keywords: Migraine
Acute Migraine
Headache
Lead sponsor: California Medical Clinic for Headache
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.

To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.

To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

Detailed description: An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.

Eligibility criteria: Inclusion Criteria:

* 15 to 70 years old
* Migraine attacks according to the criteria proposed by the IHS
* 3-12 Migraine attacks per month
* adequate contraception
* Willing and able to give written informed consent
* Willing and able to complete the entire course of the study \& comply with instructions
* Stable dose of preventive medication for at least 4 weeks

Exclusion Criteria:

* Disorders listen in groups 5-11 of the IHS Classification
* Subject is pregnant or lactating.
* Significant medical or psychiatric disease
* Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
* Subject has uncontrolled hypertension.
* Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache
* Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization
* Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan
* Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan
* Moderate/severe hepatic/renal impairment
* Subject currently using cimetidine
* Concomitant medication treatment with a triptan, ergotamine or methysergide.

Primary outcomes:
measure: Reduction of migraine headache pain from mild, moderate or severe to pain free.
timeFrame: 30 minutes post-dose
Secondary outcomes:
measure: Reduction of migraine headache pain from mild, moderate or severe to pain free.
timeFrame: 15 minutes post-dose
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
Study officials:
affiliation: California Medical Clinic for Headache
name: David B Kudrow, MD
role: PRINCIPAL_INVESTIGATOR
References: