Migraine
Conditions
Keywords
Migraine, Almotriptan Malate, Headache, Triptan
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 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.
Interventions
Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Sponsors
Ortho-McNeil Neurologics, Inc.
Janssen-Ortho LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pain Free Headaches at 2 and 24 Hours Post-Dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 55 sites in the United States.
Pre-assignment details
Of the 447 participants enrolled, 420 participants took at least one dose of study drug according to the Headache Record and were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Almotriptan Malate Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. | 447 |
| Total | 447 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Lost to Follow-up | 53 |
| Overall Study | no headache reported | 9 |
| Overall Study | various | 11 |
| Overall Study | Withdrawal by Subject | 34 |
Baseline characteristics
| Characteristic | Almotriptan Malate |
|---|---|
| Age, Continuous | 14.4 years STANDARD_DEVIATION 1.63 |
| Sex: Female, Male Female | 245 Participants |
| Sex: Female, Male Male | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 282 / 420 |
| serious Total, serious adverse events | 8 / 420 |
Outcome results
Primary
Number of Pain Free Headaches at 2 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.
Time frame: 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Pain Free Headaches at 2 and 24 Hours Post-Dose | Headaches Pain Free at 2 hours | 3218 Number of headaches |
| Almotriptan Malate | Number of Pain Free Headaches at 2 and 24 Hours Post-Dose | Headaches Pain Free at 24 hours | 5236 Number of headaches |
| Almotriptan Malate | Number of Pain Free Headaches at 2 and 24 Hours Post-Dose | Headaches Sustained Pain Free at 24 hours | 3048 Number of headaches |
Secondary
Number of Headaches Achieving Pain Relief at 2 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.
Time frame: 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose | Headaches Pain Relief at 2 hours | 3765 Number of headaches |
| Almotriptan Malate | Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose | Headaches Pain Relief at 24 hours | 4182 Number of headaches |
| Almotriptan Malate | Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose | Headaches Sustained Pain Relief at 24 hours | 3384 Number of headaches |
Secondary
Number of Headaches With Nausea
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.
Time frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Headaches With Nausea | At baseline | 3262 Number of headaches with nausea |
| Almotriptan Malate | Number of Headaches With Nausea | At 2 hours | 1785 Number of headaches with nausea |
| Almotriptan Malate | Number of Headaches With Nausea | At 24 hours | 542 Number of headaches with nausea |
Secondary
Number of Headaches With Phonophobia
Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.
Time frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Headaches With Phonophobia | At 2 hours | 2847 Number of headaches with phonophobia |
| Almotriptan Malate | Number of Headaches With Phonophobia | At 24 hours | 805 Number of headaches with phonophobia |
| Almotriptan Malate | Number of Headaches With Phonophobia | At baseline | 5783 Number of headaches with phonophobia |
Secondary
Number of Headaches With Photophobia
Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.
Time frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Headaches With Photophobia | At baseline | 6164 Number of headaches with photophobia |
| Almotriptan Malate | Number of Headaches With Photophobia | At 2 hours | 3150 Number of headaches with photophobia |
| Almotriptan Malate | Number of Headaches With Photophobia | At 24 hours | 936 Number of headaches with photophobia |
Secondary
Number of Headaches With Vomiting
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.
Time frame: Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Population: Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Almotriptan Malate | Number of Headaches With Vomiting | At baseline | 357 Number of headaches with vomiting |
| Almotriptan Malate | Number of Headaches With Vomiting | At 2 hours | 258 Number of headaches with vomiting |
| Almotriptan Malate | Number of Headaches With Vomiting | At 24 hours | 107 Number of headaches with vomiting |