A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Tracking Information | |||||
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First Received Date ICMJE | November 18, 2005 | ||||
Last Updated Date | May 16, 2011 | ||||
Start Date ICMJE | November 2005 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
An assessment of the long-term safety (incidence of adverse events, changes in physical and neurological examinations, ECGs and laboratory tests) | ||||
Original Primary Outcome Measures ICMJE |
An assessment of the long-term safety (incidence of adverse events, changes in physical and neurological examinations, ECGs and laboratory tests) | ||||
Change History | Complete list of historical versions of study NCT00257010 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 | ||||
Original Secondary Outcome Measures ICMJE |
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 | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches | ||||
Official Title ICMJE | Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: almotriptan malate | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 447 | ||||
Completion Date | December 2007 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 12 Years to 17 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00257010 | ||||
Other Study ID Numbers ICMJE | CR002827 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Janssen-Ortho LLC | ||||
Collaborators ICMJE | Ortho-McNeil Neurologics, Inc. | ||||
Investigators ICMJE |
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Information Provided By | Janssen-Ortho LLC | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |