Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. FDA label
Also known as Maxalt, MK-0462, rizatriptan benzoate
Rizatriptan · 12 trials · 6 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 intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.
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.
Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.
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
Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.
Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE). A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
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 |
| Stage 1: rizatriptan | EXPERIMENTAL | - |
| Stage 1: placebo | PLACEBO_COMPARATOR | - |
| Stage 2: rizatriptan | EXPERIMENTAL | - |
| Stage 2: placebo | PLACEBO_COMPARATOR | - |
| Treatment Sequence A | EXPERIMENTAL | Rizatriptan - Rizatriptan - Placebo |
| Treatment Sequence B | EXPERIMENTAL | Rizatriptan - Placebo - Rizatriptan |
| Treatment Sequence C | EXPERIMENTAL | Placebo - Rizatriptan - Rizatriptan |
| Baseline Phase | OTHER | Sumatriptan |
| 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 5 mg | EXPERIMENTAL | Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) |
| Rizatriptan 10 mg | EXPERIMENTAL | Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) |
| Standard Care | ACTIVE_COMPARATOR | Standard care at onset of migraine attack |
| 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 |
| rizatriptan | DRUG | For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. |
| placebo | DRUG | For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine. |
| Comparator: Placebo | DRUG | Placebo to Rizatriptan |
| Comparator: Sumatriptan | DRUG | single dose of generic sumatriptan 100 mg at onset of migraine attack |
| Comparator: rizatriptan benzoate | DRUG | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Comparator: Rizatriptan | DRUG | One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack. |
| rizatriptan benzoate (MK0462) | DRUG | single dose 5 mg rizatriptan p.o. |
| Rizatriptan 5 mg | DRUG | Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) |
| Rizatriptan 10 mg | DRUG | Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) |
| Standard Care | DRUG | Active standard care |
| 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 is used for the acute treatment of migraine and migraine disorders in adults and, in some studies, in children and adolescents. It is a small molecule developed by Organon & Co. (ticker: OGN) and has been evaluated in Phase 3 clinical trials for these indications.
Rizatriptan targets the serotonin receptors HTR1B and HTR1D, where it acts as an agonist. By activating these receptors, it is thought to help relieve migraine symptoms. This mechanism is consistent with its classification as a small molecule agonist in the neurology therapeutic area.
Rizatriptan is developed by Organon & Co., which trades under the ticker OGN. The company has sponsored Phase 3 clinical trials of the drug for acute migraine and migraine disorders.
Rizatriptan has been studied in Phase 3 clinical trials. Two completed trials are listed, with no active trials currently reported. It is an investigational product in the context of these trials and has been evaluated for acute migraine and migraine disorders.
Rizatriptan has been evaluated in completed Phase 3 trials including NCT01286207, a long-term extension study; NCT01001234, a pediatric acute migraine study; NCT00894556, an acute migraine study; and NCT00250458, a study in migraine-associated nausea. All trials are completed.