Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257010
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2005-11-18
Brief Title:
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Sponsor:
Janssen-Ortho LLC
Organization:
Janssen-Ortho LLC
Study Overview
Official Title:
Long-Term Open-Label Safety Study of Oral Almotriptan Malate 125 mg in the Treatment of Migraine in Adolescents
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 125 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 125 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAPSS-368 | OTHER | Janssen-Ortho LLC | None |