Clinical trial NCT00257010: A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Official title: Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Almotriptan Malate
Headache
Triptan
Lead sponsor: Janssen-Ortho LLC
Sponsor class: INDUSTRY
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-11-22
Enrollment: 447
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

Detailed description: Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Eligibility criteria: Inclusion Criteria:

* Have a history of migraine for at least one year
* Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
* Able to swallow oral medication
* Able to complete a headache diary
* Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)

Exclusion Criteria:

* Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
* Have 15 or more days within a month in which you have a headache
* Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
* Experience more than 6 non-migraine headaches per month

Primary outcomes:
measure: Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
timeFrame: 2 hours and 24 hours post-dose
Secondary outcomes:
measure: Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
timeFrame: 2 hours and 24 hours post-dose
measure: Number of Headaches With Photophobia
timeFrame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
measure: Number of Headaches With Phonophobia
timeFrame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
measure: Number of Headaches With Nausea
timeFrame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
measure: Number of Headaches With Vomiting
timeFrame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Oxford
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Santa Monica
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Loxahatchee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Witchita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Ann Arbor
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Endwell
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Mount Vernon
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Alcoa
country: United States
state: Tennessee
city: Bristol
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Morristown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Marcos
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Janssen-Ortho LLC
name: Janssen Ortho LLC Clinical Trial
role: STUDY_DIRECTOR
References: