Phase 3
N=447
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00257010 ↗Enrolled (actual)
447
Serious AEs
1.9%
Results posted
Dec 2013
Primary outcome: Primary: Number of Pain Free Headaches at 2 and 24 Hours Post-Dose — 3218; 5236; 3048 Number of headaches
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Almotriptan Malate (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Janssen-Ortho LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pain Free Headaches at 2 and 24 Hours Post-Dose |
3218; 5236; 3048 | — |
| SECONDARY Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose |
3765; 4182; 3384 | — |
| SECONDARY Number of Headaches With Photophobia |
6164; 3150; 936 | — |
| SECONDARY Number of Headaches With Phonophobia |
5783; 2847; 805 | — |
| SECONDARY Number of Headaches With Nausea |
3262; 1785; 542 | — |
| SECONDARY Number of Headaches With Vomiting |
357; 258; 107 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00257010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.