Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TREXIMET · 1 trial · 2 indications
SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.
| Arm | Type | Description |
|---|---|---|
| TPB | OTHER | TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) |
| TBP | OTHER | TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) |
| BTP | OTHER | BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) |
| BPT | OTHER | BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) |
| PTB | OTHER | placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) |
| PBT | OTHER | placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3) |
| Name | Type | Description |
|---|---|---|
| TREXIMET® | DRUG | Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) |
| Butalbital-containing Combination Medications (BCM) | DRUG | butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\] |
| placebo | DRUG | placebo |
Inclusion Criteria: * Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception i...
TREXIMET is used for the acute treatment of migraine in adults. It is a small molecule being developed by GSK plc for migraine disorders. The drug is currently in Phase 3 clinical development and is being studied for its efficacy in treating acute migraine attacks.
TREXIMET is a small molecule being developed for the acute treatment of migraine. The specific molecular target of TREXIMET has not been disclosed in the available information. The drug is being evaluated in a Phase 3 clinical trial for its ability to treat migraine attacks in adults.
TREXIMET is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of TREXIMET for the acute treatment of migraine in adults.
TREXIMET is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the acute treatment of migraine in adults, and its clinical trial has been completed.
TREXIMET has been studied in a Phase 3 clinical trial with the identifier NCT00573170. This trial, titled 'TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults,' was a randomized, double-blind, controlled study that enrolled 375 participants in the United States. The trial has been completed.
TREXIMET is a brand name for a combination medication. While the specific alternative names are not provided, TREXIMET contains a combination of active ingredients. It is being developed by GSK plc for the acute treatment of migraine in adults and is currently in Phase 3 clinical development.