Migraine
Conditions
Brief summary
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
Interventions
DRUGComparator: rizatriptan benzoate
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
DRUGComparator: Placebo
Matching placebo; one dose, treatment of a single migraine attack
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than one year history of migraine * Attacks typically mild when they begin and progress to moderate or severe * Experience 1-4 migraine attacks per month
Exclusion criteria
* More than 15 headache days per month * Heart disease * Uncontrolled high blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Pain Free at 2 Hours Post-Dose | 2 hours post-dose | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With no Rescue Use up to 24 Hours Post-Dose | 24 hours post-dose | Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary. |
| Number of Participants With Absence of Photophobia at 2 Hours Post-dose | 2 hours post-dose | Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose. |
| Number of Participants With 24-Hour Sustained Pain Freedom | 24 hours post-dose | 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary. |
| Number of Participants With Absence of Nausea at 2 Hours Post-dose | 2 hours post-dose | Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose. |
| Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | 2 hours post-dose | Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose. |
| Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | 2 hours post-dose | Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose. |
Participant flow
Recruitment details
Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)
Pre-assignment details
Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
Participants by arm
| Arm | Count |
|---|---|
| Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack | 103 |
| Placebo Matching placebo; one dose, treatment of a single migraine attack | 104 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Qualifying Event | 9 | 6 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Rizatriptan 10 mg ODT | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 44 years | 42.5 years |
| Race/Ethnicity, Customized Asian | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Multi-Racial | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White | 95 participants | 100 participants | 195 participants |
| Sex: Female, Male Female | 90 Participants | 96 Participants | 186 Participants |
| Sex: Female, Male Male | 13 Participants | 8 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 92 | 3 / 96 |
| serious Total, serious adverse events | 0 / 92 | 0 / 96 |
Outcome results
Primary
Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Time frame: 2 hours post-dose
Population: Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants Who Are Pain Free at 2 Hours Post-Dose | 61 Participants |
| Placebo | Number of Participants Who Are Pain Free at 2 Hours Post-Dose | 27 Participants |
Secondary
Number of Participants With 24-Hour Sustained Pain Freedom
24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Time frame: 24 hours post-dose
Population: The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With 24-Hour Sustained Pain Freedom | 48 Participants |
| Placebo | Number of Participants With 24-Hour Sustained Pain Freedom | 17 Participants |
Secondary
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
Time frame: 2 hours post-dose
Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | 66 Participants |
| Placebo | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | 42 Participants |
Secondary
Number of Participants With Absence of Nausea at 2 Hours Post-dose
Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Time frame: 2 hours post-dose
Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With Absence of Nausea at 2 Hours Post-dose | 82 Participants |
| Placebo | Number of Participants With Absence of Nausea at 2 Hours Post-dose | 73 Participants |
Secondary
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Time frame: 2 hours post-dose
Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | 72 Participants |
| Placebo | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | 55 Participants |
Secondary
Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Time frame: 2 hours post-dose
Population: The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With Absence of Photophobia at 2 Hours Post-dose | 69 Participants |
| Placebo | Number of Participants With Absence of Photophobia at 2 Hours Post-dose | 43 Participants |
Secondary
Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Time frame: 24 hours post-dose
Population: The FAS population included all randomized and treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rizatriptan 10 mg ODT | Number of Participants With no Rescue Use up to 24 Hours Post-Dose | 61 Participants |
| Placebo | Number of Participants With no Rescue Use up to 24 Hours Post-Dose | 32 Participants |