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A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches

Information source: Janssen-Ortho LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Almotriptan Malate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen-Ortho LLC

Official(s) and/or principal investigator(s):
Janssen Ortho LLC Clinical Trial, Study Director, Affiliation: Janssen-Ortho LLC


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.

Clinical Details

Official title: Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Pain Free Headaches at 2 and 24 Hours Post-Dose

Secondary outcome:

Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose

Number of Headaches With Photophobia

Number of Headaches With Phonophobia

Number of Headaches With Nausea

Number of Headaches With Vomiting

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.


Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.


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

Locations and Contacts

Mobile, Alabama, United States

Montgomery, Alabama, United States

Oxford, Alabama, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Santa Monica, California, United States

Centennial, Colorado, United States

Denver, Colorado, United States

Loxahatchee, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Snellville, Georgia, United States

Idaho Falls, Idaho, United States

Chicago, Illinois, United States

Des Moines, Iowa, United States

Topeka, Kansas, United States

Witchita, Kansas, United States

Louisville, Kentucky, United States

Ann Arbor, Michigan, United States

Columbia, Missouri, United States

Saint Louis, Missouri, United States

Springfield, Missouri, United States

Endwell, New York, United States

Mineola, New York, United States

Mount Vernon, New York, United States

Plainview, New York, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Alcoa, Tennessee, United States

Bristol, Tennessee, United States

Germantown, Tennessee, United States

Morristown, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

San Marcos, Texas, United States

Salt Lake City, Utah, United States

Madison, Wisconsin, United States

Additional Information

Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment ofMigraine in Adolescents

Starting date: December 2005
Last updated: January 23, 2014

Page last updated: August 23, 2015

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