Acute Migraine With or Without Aura in Adolescents
Conditions
Keywords
acute migraine with or without aura in adolescents
Brief summary
To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.
Interventions
Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack
Sponsors
Organon and Co
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
* Patient is between 12 and 17 years of age inclusive at screening Visit 1 * Patient weighs at least 20 kg (44 pounds) * Patient has had a history of unilateral or bilateral migraine headache with or without aura \>6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1 * Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions * The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent * For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1
Exclusion criteria
* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation * Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours * Patient has basilar or hemiplegic migraine headaches * Patient has \>15 headache-days per month OR has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening * Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any cancer, or any other significant disease * Patient has a history cardiovascular problems or stroke * Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan * Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription) * Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists * Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a recreational user of illicit drugs * Patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required * Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening * Patient is legally or mentally incapacitated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose | Up to 24 hours post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary. |
| Number of Participants With AEs Within 14 Days Post Any Dose | Up to 14 days post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary. |
| Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | Up to 24 hours post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary. |
| Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | Up to 14 days post dose | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | 2 hours post dose | Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated. |
Participant flow
Pre-assignment details
A total of 674 patients met inclusion/exclusion criteria and were allocated study drug. Of these, 606 were treated with study drug.
Participants by arm
| Arm | Count |
|---|---|
| Rizatriptan Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if \<40 kg, 10 mg if ≥40 kg). | 606 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lack of Qualifying Event | 2 |
| Overall Study | Lost to Follow-up | 64 |
| Overall Study | Physician Decision | 15 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Protocol Violation | 10 |
| Overall Study | Withdrawal by Subject | 58 |
Baseline characteristics
| Characteristic | Rizatriptan |
|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 372 Participants |
| Sex: Female, Male Male | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 284 / 606 |
| serious Total, serious adverse events | 22 / 606 |
Outcome results
Primary
Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.
Time frame: Up to 14 days post dose
Population: All enrolled participants who administered at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan | Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose | 14 participants |
Primary
Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.
Time frame: Up to 24 hours post dose
Population: All enrolled participants who administered at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan | Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose | 4 participants |
Primary
Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.
Time frame: Up to 24 hours post dose
Population: All enrolled participants who administered at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan | Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose | 322 participants |
Primary
Number of Participants With AEs Within 14 Days Post Any Dose
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.
Time frame: Up to 14 days post dose
Population: All enrolled participants who administered at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan | Number of Participants With AEs Within 14 Days Post Any Dose | 400 participants |
Secondary
Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.
Time frame: 2 hours post dose
Population: All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rizatriptan | Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose | 46.3 percentage of participant's attacks | Standard Deviation 31.9 |