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

Condition(s) targeted: Common Migraine; Migraine; Classic 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.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: An assessment of the long-term safety (incidence of adverse events, changes in physical and neurological examinations, ECGs and laboratory tests)

Secondary outcome: Percent of episodes that are headache pain-free at 2 hours post-dosing; headache pain relief at 2 hours post-dosing; occurrence and intensity of migraine symptoms at 2 hours and 24 hours post-dosing; occurrence of vomiting within 24 hours of dosing

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.

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

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm

Starting date: November 2005
Ending date: December 2007
Last updated: March 6, 2008