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A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Janssen-Ortho LLC
ClinicalTrials.gov Identifier:
NCT00210509
First received: September 13, 2005
Last updated: May 16, 2011
Last verified: April 2010

September 13, 2005
May 16, 2011
November 2004
Not Provided
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
Same as current
Complete list of historical versions of study NCT00210509 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache
AXERT® Early miGraine Intervention Study (AEGIS): Efficacy and Safety of Almotriptan Malate (AXERT®) Versus Placebo for the Acute Treatment of Migraine Headache

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.

Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of adult patients with a diagnosis of migraine headache, with or without aura. Patients will be randomized (like with the toss of a coin) to receive almotriptan malate (AXERT®) or placebo for the treatment of 3 consecutive qualifying migraine headaches. After screening, patients will leave the study center with blinded study medication and an electronic subject diary (Personal Digital Assistant [PDA]). Patients will self-dose with study medication as soon as headache pain of any intensity begins (that resembles their usual migraine), but no later than 1 hour after headache pain begins. Patients will use their PDAs to record assessments such as pain intensity, symptom severity and ability to function as related to the headaches. The primary hypothesis of this study is that the percentage of patients who are pain free two hours after taking study drug at the earliest onset of headache pain is greater in the almotriptan malate (AXERT®) 12.5mg group than in the placebo group and almotriptan malate (AXERT®) is generally well-tolerated.

Almotriptan malate (AXERT®) 12.5 milligrams or placebo tablets, one by mouth at the beginning of migraine pain (within 1 hour) for 3 consecutive migraine headaches

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Migraine
Drug: almotriptan malate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
378
June 2005
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Pregnant or breast-feeding
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00210509
CR004714
Not Provided
Not Provided
Janssen-Ortho LLC
Ortho-McNeil Neurologics, Inc.
Study Director: Janssen Ortho LLC Clinical Trial Janssen-Ortho LLC
Janssen-Ortho LLC
April 2010

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