Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rizatriptan · 3 trials · 3 indications
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
| 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 |
Inclusion Criteria: * Patient weighs at least 20 kg (44 pounds) * Patient has had a history of migraine with or without aura \> 6 months with \>= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1 * Patient has a history of migraine defined by Intern...
Rizatriptan is used for the acute treatment of migraine, including migraine-associated nausea. It is being studied in adults and in children and adolescents aged 6 years and older. The drug is a small molecule in development for migraine disorders and acute migraine.
Rizatriptan is a triptan that works by binding to serotonin receptors, which constricts blood vessels in the brain and reduces inflammation, helping to relieve migraine pain. It is a small molecule developed for the acute treatment of migraine.
Rizatriptan is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is in Phase 3 clinical development for the treatment of migraine.
Rizatriptan is in Phase 3 clinical development. It is an investigational drug, not yet approved by the FDA, and is being studied for the acute treatment of migraine in adults and children.
Rizatriptan has completed four Phase 3 trials, including NCT00250458 for migraine-associated nausea, NCT00894556 for acute migraine, NCT01001234 for acute migraine in children and adolescents, and NCT01286207 for long-term exposure in migraine disorders.
Rizatriptan is the generic name for the migraine medication marketed as Maxalt. The drug is being studied under the name rizatriptan in clinical trials for acute migraine treatment.