Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rizatriptan benzoate · 8 trials · 4 indications
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.
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.
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.
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.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 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.
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment
Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack
Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
| Arm | Type | Description |
|---|---|---|
| Rizatriptan | EXPERIMENTAL | Rizatriptan benzoate |
| A | EXPERIMENTAL | Treatment Sequence A: rizatriptan, rizatriptan, placebo |
| B | EXPERIMENTAL | Sequence B: rizatriptan, placebo, rizatriptan |
| C | EXPERIMENTAL | Sequence C: placebo, rizatriptan, rizatriptan |
| 1 | EXPERIMENTAL | Active Drug |
| 2 | PLACEBO_COMPARATOR | Matching Pbo Comparator |
| 3 | ACTIVE_COMPARATOR | sumatriptan 100 mg |
| 4 | PLACEBO_COMPARATOR | placebo |
| Treatment Sequence 1 | EXPERIMENTAL | Placebo-Rizatriptan-Rizatriptan-Rizatriptan |
| Treatment Sequence 2 | EXPERIMENTAL | Rizatriptan-Placebo-Rizatriptan-Rizatriptan |
| Treatment Sequence 3 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Placebo-Rizatriptan |
| Treatment Sequence 4 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Rizatriptan-Placebo |
| Treatment Sequence 5 | EXPERIMENTAL | Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan |
| Rizatriptan 10 mg | EXPERIMENTAL | - |
| Rizatriptan 5 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Panel A Rizatriptan | EXPERIMENTAL | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| Panel A Placebo | PLACEBO_COMPARATOR | Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. |
| Panel B Rizatriptan | EXPERIMENTAL | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| Panel B Placebo | PLACEBO_COMPARATOR | Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B. |
| Panel C Rizatriptan | EXPERIMENTAL | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
| Panel C Placebo | PLACEBO_COMPARATOR | Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group. |
| Name | Type | Description |
|---|---|---|
| rizatriptan benzoate | DRUG | Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack |
| Comparator: placebo | DRUG | Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack |
| Comparator: rizatriptan benzoate | DRUG | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Comparator: sumatriptan | DRUG | single dose administration of sumatriptan 100 p.o. |
| rizatriptan benzoate (MK0462) | DRUG | single dose 5 mg rizatriptan p.o. |
| rizatriptan benzoate (5 mg) | DRUG | A single dose of rizatriptan 5 mg administered on Day 1. |
| rizatriptan benzoate (10 mg) | DRUG | A single dose of rizatriptan 10 mg administered on Day 1. |
| Rizatriptan 5 mg Placebo | DRUG | A single dose of rizatriptan 5 mg placebo administered on Day 1. |
| Rizatriptan 10 mg Placebo | DRUG | A single dose of rizatriptan 10 mg placebo administered on Day 1. |
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...
Rizatriptan benzoate is used for the acute treatment of migraine, including migraine headache and acute migraine with or without aura in adolescents. It is being studied for migraine disorders in both pediatric and adult populations.
Rizatriptan benzoate is a small molecule that acts as a selective serotonin receptor agonist, specifically targeting 5-HT1B and 5-HT1D receptors to constrict cranial blood vessels and inhibit pro-inflammatory neuropeptide release, which helps relieve migraine symptoms.
Rizatriptan benzoate is developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN.
Rizatriptan benzoate is in Phase 3 clinical development for migraine indications. It is an investigational drug and has not been approved by the FDA for these uses.
Rizatriptan benzoate has completed four clinical trials, including NCT00604812 in pediatric subjects with migraines, NCT00898677 comparing rizatriptan to sumatriptan and placebo, NCT00899379 for multiple acute migraine attacks, and NCT01004263 for long-term safety in children and adolescents.
Rizatriptan benzoate is the active ingredient in the brand-name medication Maxalt, which is used to treat acute migraine attacks. The drug is being studied under its generic name in these clinical trials.