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Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

This study has been completed.
Sponsor:
Information provided by:
California Medical Clinic for Headache
ClinicalTrials.gov Identifier:
NCT01276977
First received: January 11, 2011
Last updated: January 13, 2011
Last verified: January 2011

January 11, 2011
January 13, 2011
April 2008
December 2010   (final data collection date for primary outcome measure)
Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 30 minutes post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276977 on ClinicalTrials.gov Archive Site
Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 15 minutes post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Migraine
  • Migraine Headache
  • Headache Disorders
  • Drug: Zolmitriptan 5 mg Nasal Spray
    Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
  • Drug: Eletriptan 40 mg tablet
    Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
  • Experimental: Zolmitriptan 5 mg nasal spray
    Interventions:
    • Drug: Zolmitriptan 5 mg Nasal Spray
    • Drug: Eletriptan 40 mg tablet
  • Active Comparator: Eletriptan 40 mg Tablet
    Interventions:
    • Drug: Zolmitriptan 5 mg Nasal Spray
    • Drug: Eletriptan 40 mg tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01276977
IRUSZOLM0028
No
David Kudrow, M.D., California Medical Clinic for Headache
California Medical Clinic for Headache
Not Provided
Principal Investigator: David B Kudrow, MD California Medical Clinic for Headache
California Medical Clinic for Headache
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP