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

NCT ID: NCT00257010

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-12-31

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.

Conditions

Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Almotriptan Malate

Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Group Type: EXPERIMENTAL

Almotriptan Malate

Intervention Type: DRUG

Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Interventions

Almotriptan Malate

Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: collaborator

Janssen-Ortho LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Ortho LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Ortho LLC

Locations

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 Groves, 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

Springfield, Missouri, United States

St Louis, 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

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=290&filename=CR002827_CSR.pdf

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

Other Identifiers

CAPSS-368

Identifier Type: OTHER

Identifier Source: secondary_id

CR002827

Identifier Type: -

Identifier Source: org_study_id