Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eletriptan HBr · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Eletriptan HBr 40 mg | EXPERIMENTAL | - |
| Eletriptan HBr 80 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random. |
| Eletriptan HBr 40 mg | DRUG | All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random. |
| Eletriptan HBr 80 mg | DRUG | All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random. |
Inclusion Criteria: * Male and Female subjects in good general health, aged 18 to 65 years. * Subjects should meet IHS diagnostic criteria for migraine with or without aura. * Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 ...
Eletriptan HBr is a small molecule drug being developed by Pfizer for the treatment of migraine without aura. It is currently in Phase 3 clinical development and is being studied as an acute treatment for migraine attacks. The drug is administered orally and has been evaluated in a randomized, double-blind, placebo-controlled trial.
Eletriptan HBr is a selective serotonin receptor agonist that works by binding to serotonin receptors in the brain, which causes constriction of cranial blood vessels and reduces inflammation. This action helps to relieve the pain and other symptoms associated with migraine attacks. The drug is specifically designed to target the underlying mechanisms of migraine.
Eletriptan HBr is being developed by Pfizer, Inc., a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the clinical development and potential commercialization of this drug for the treatment of migraine without aura.
Eletriptan HBr is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind, placebo-controlled study. The drug is not yet approved by regulatory authorities and remains an investigational agent. Further clinical development may be required before it can be considered for regulatory approval.
Eletriptan HBr has been studied in a Phase 3 clinical trial with the identifier NCT01859481. This trial, titled 'Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study,' enrolled 971 participants and was conducted across multiple countries including Belgium, France, Germany, and Spain. The study has been completed.
Eletriptan HBr is the active ingredient in the brand-name medication Relpax. Relpax is a prescription drug used for the acute treatment of migraine attacks with or without aura in adults. The drug has been available for many years and is well-established in the treatment of migraines.