Approval Probability
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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 developed by Pfizer, Inc. (PFE) for the treatment of migraine without aura. It is also known as Eletriptan HBr 40 mg. It is currently in Phase 3 clinical development. The drug has been studied in a completed Phase 3 trial that enrolled 971 patients.
Eletriptan HBr is used for the acute treatment of migraine without aura. It is a small molecule therapeutic in the neurology area. The drug has been evaluated in a Phase 3 trial for migraine without aura and migraine with aura. It is not indicated for migraine prevention.
Eletriptan HBr targets the serotonin receptors HTR1B, HTR1D, and HTR1F, where it acts as an agonist. By activating these receptors, it is thought to produce vasoconstriction and inhibit neurogenic inflammation, which may relieve migraine symptoms. This mechanism is consistent with its use in migraine without aura.
Eletriptan HBr is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this small molecule drug for migraine without aura.
Eletriptan HBr is in Phase 3 clinical development. It has not been approved by the FDA for any indication. The drug has completed one Phase 3 trial and is considered investigational.
Eletriptan HBr has been studied in a completed Phase 3 clinical trial, NCT01859481, titled "Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study." This randomized, double-blind, placebo-controlled trial enrolled 971 patients with migraine without aura and migraine with aura across multiple countries in Europe and Turkey.