NCT00210509

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12.5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_4

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

November 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

May 16, 2011

Conditions

Migraine

Keywords

auraMigrainepainheadache

Outcome Measures

Primary Outcomes (1)

  • Effectiveness: pain free at 2 hours (defined as a decrease from severe, moderate or mild to no pain) without the use of supplemental pain medication and/or antiemetic medication up to the 2 hour timepoint

Secondary Outcomes (1)

  • Effectiveness: time to pain free post-dosing; timed assessments to achieve pain relief at 0.5, 1, 2, 4 and 24 hours post-dosing; consistency of response; migraine-associated symptoms; migraine-associated vomiting; change in functional disability

Interventions

almotriptan malateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of migraine, with or without aura
  • At least moderate pain with migraines
  • Average of 2 to 6 migraines per month for past 3 months
  • Duration of headache pain at least 4 hours
  • Able to tell the difference between a migraine and a tension headache
  • If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening
  • In generally good health
  • If female, using birth control

You may not qualify if:

  • Routinely experience other type of headache that might seem like a migraine headache
  • An average of 15 or more headache days per month in the past 6 months
  • Migraines began after age 50
  • Taking \> 1 medicine for preventing migraines
  • Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days
  • Use of non-drug treatment for migraine in past 14 days unless have used this treatment for \> 14 days and plan to continue throughout study
  • Overuse of medications that treat pain or nausea
  • Migraine aura without headache
  • Hemiplegic or basilar migraines
  • Usually have vomiting with headache
  • Headaches that usually occur upon waking
  • Significant unstable medical disease
  • Abnormal liver, kidney, blood, or ECG laboratory or test results
  • Abusing drugs or alcohol
  • History of a significant mental disorder
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mathew NT, Finlayson G, Smith TR, Cady RK, Adelman J, Mao L, Wright P, Greenberg SJ; AEGIS Investigator Study Group. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Headache. 2007 Feb;47(2):189-98. doi: 10.1111/j.1526-4610.2006.00686.x.

    PMID: 17300358RESULT

Related Links

MeSH Terms

Conditions

Migraine DisordersEpilepsyPainHeadache

Interventions

almotriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Ortho LLC Clinical Trial

    Janssen-Ortho LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Study Completion

June 1, 2005

Last Updated

May 17, 2011

Record last verified: 2010-04