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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Almotriptan Malate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almotriptan Malate<br>Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain | Drug: Almotriptan Malate<br>* Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pain Free Headaches at 2 and 24 Hours Post-Dose | Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours. | 2 hours and 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose | Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours. | 2 hours and 24 hours post-dose | 
| Number of Headaches With Photophobia | Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes. | Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose | 
| Number of Headaches With Phonophobia | Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise. | Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose | 
| Number of Headaches With Nausea | Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit. | Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose | 
| Number of Headaches With Vomiting | Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis. | Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Almotriptan Malate, Headache, Triptan