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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: Almotriptan Malate	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	447 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents
Study Start Date :	December 2005
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Almotriptan Malate; Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain	Drug: Almotriptan Malate; Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain

Outcome Measures

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Primary Outcome Measures :

1. Number of Pain Free Headaches at 2 and 24 Hours Post-Dose [ Time Frame: 2 hours 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.

Secondary Outcome Measures :

1. Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose [ Time Frame: 2 hours 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. Number of Headaches With Photophobia [ Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose ]
   Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.
3. Number of Headaches With Phonophobia [ Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose ]
   Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.
4. Number of Headaches With Nausea [ Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose ]
   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.
5. Number of Headaches With Vomiting [ Time Frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 49 Study Locations

Sponsors and Collaborators

Janssen-Ortho LLC

Ortho-McNeil Neurologics, Inc.

Investigators

Study Director:	Janssen Ortho LLC Clinical Trial	Janssen-Ortho LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Responsible Party:	Janssen-Ortho LLC
ClinicalTrials.gov Identifier:	NCT00257010 History of Changes
Other Study ID Numbers:	CR002827; CAPSS-368 ( Other Identifier: Janssen-Ortho LLC )
First Posted:	November 22, 2005
Results First Posted:	December 6, 2013
Last Update Posted:	February 21, 2014
Last Verified:	January 2014

Keywords provided by Janssen-Ortho LLC:

Migraine; Almotriptan Malate; Headache; Triptan

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Almotriptan; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs