A Phase 3 interventional study of Comparator: rizatriptan benzoate and Comparator: Placebo in Migraine, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 207 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Active Drug
Drug: Comparator: rizatriptan benzoate
Matching Pbo Comparator
Drug: Comparator: Placebo
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Also known as: MK0462
Matching placebo; one dose, treatment of a single migraine attack
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
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
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
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
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
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
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
Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)
| Milestone | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Started | 103 | 104 |
| Completed | 92 | 96 |
| Not completed | 11 | 8 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lack of qualifying event | 9 | 6 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants Who Are Pain Free at 2 Hours Post-Dose | 61 | 27 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With 24-Hour Sustained Pain Freedom | 48 | 17 |
Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With no Rescue Use up to 24 Hours Post-Dose | 61 | 32 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With Absence of Photophobia at 2 Hours Post-dose | 69 | 43 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | 72 | 55 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With Absence of Nausea at 2 Hours Post-dose | 82 | 73 |
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.
| Participants | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | 66 | 42 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rizatriptan 10 mg ODT | — | 0/92 (0%) | 6/92 (6.5%) |
| Placebo | — | 0/96 (0%) | 3/96 (3.1%) |
| Event | Rizatriptan 10 mg ODT | Placebo |
|---|---|---|
| HyperchlorhydriaGastrointestinal disorders | 2/92 | 0/96 |
| DizzinessNervous system disorders | 2/92 | 1/96 |
| NauseaGastrointestinal disorders | 1/92 | 0/96 |
| Feeling jitteryGeneral disorders | 1/92 | 0/96 |
| PainGeneral disorders | 1/92 | 0/96 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/92 | 0/96 |
| Balance disorderNervous system disorders | 1/92 | 0/96 |
| Throat tightnessRespiratory, thoracic and mediastinal disorders | 1/92 | 0/96 |
| FatigueGeneral disorders | 0/92 | 1/96 |
| Feeling coldGeneral disorders | 0/92 | 1/96 |
| Age, Continuous(years) | Rizatriptan 10 mg ODT | Placebo | Total |
|---|---|---|---|
| Mean | 41 (19 to 69) | 44 (18 to 66) | 42.5 (18 to 69) |
| Sex: Female, Male(Participants) | Rizatriptan 10 mg ODT | Placebo | Total |
|---|---|---|---|
| Female | 90 | 96 | 186 |
| Male | 13 | 8 | 21 |
| Race/Ethnicity, Customized(participants) | Rizatriptan 10 mg ODT | Placebo | Total |
|---|---|---|---|
| Black or African American | 4 | 3 | 7 |
| White | 95 | 100 | 195 |
| Asian | 2 | 1 | 3 |
| Multi-Racial | 2 | 0 | 2 |
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rizatriptan