A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
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ClinicalTrials.gov Identifier: NCT00257010 |
Recruitment Status
:
Completed
First Posted
: November 22, 2005
Results First Posted
: December 6, 2013
Last Update Posted
: February 21, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Almotriptan Malate | Phase 3 |
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 |
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
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Drug: Almotriptan Malate
Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257010

Study Director: | Janssen Ortho LLC Clinical Trial | Janssen-Ortho LLC |
Additional Information:
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 Key Record Dates |
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 |