NCT01276977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
Last Updated

January 14, 2011

Status Verified

January 1, 2011

Enrollment Period

2.7 years

First QC Date

January 11, 2011

Last Update Submit

January 13, 2011

Conditions

Acute MigraineMigraine HeadacheHeadache Disorders

Keywords

MigraineAcute MigraineHeadache

Outcome Measures

Primary Outcomes (1)

  • Reduction of migraine headache pain from mild, moderate or severe to pain free.

    30 minutes post-dose

Secondary Outcomes (1)

  • Reduction of migraine headache pain from mild, moderate or severe to pain free.

    15 minutes post-dose

Study Arms (2)

Zolmitriptan 5 mg nasal spray

EXPERIMENTAL
Drug: Zolmitriptan 5 mg Nasal SprayDrug: Eletriptan 40 mg tablet

Eletriptan 40 mg Tablet

ACTIVE COMPARATOR
Drug: Zolmitriptan 5 mg Nasal SprayDrug: Eletriptan 40 mg tablet

Interventions

Zolmitriptan 5 mg Nasal SprayDRUG

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Eletriptan 40 mg TabletZolmitriptan 5 mg nasal spray
Eletriptan 40 mg tabletDRUG

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Eletriptan 40 mg TabletZolmitriptan 5 mg nasal spray

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years old
  • Migraine attacks according to the criteria proposed by the IHS
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Migraine DisordersHeadache DisordersHeadache

Interventions

zolmitriptanNasal SprayseletriptanTablets

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • David B Kudrow, MD

    California Medical Clinic for Headache

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 14, 2011

Study Start

April 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 14, 2011

Record last verified: 2011-01

Locations

US(1)