Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trigeminal Nerve Stimulation · 1 trial · 2 indications
Change in responder rate, at end of study (18 weeks) Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.
Number of Days to the 4th seizure
Percent change in seizure frequency from baseline
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Control | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Trigeminal Nerve Stimulation | DEVICE | External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit |
Inclusion Criteria: * Ages 18 - 70; * No serious or progressive medical illness; * A history of intractable partial seizures; * At least two complex partial or tonic clonic generalized seizures per month in the last two consecutive months; * MRI or EEG consistent with localization-related or partia...
Trigeminal Nerve Stimulation is an investigational therapy being studied for the treatment of epilepsy and seizure disorders. It is a form of nerve stimulation that is currently in Phase 2 clinical development. The therapy is being evaluated for its potential to reduce seizure activity in patients with epilepsy.
Trigeminal Nerve Stimulation is being developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical research to evaluate this therapy for epilepsy and seizure disorders.
Trigeminal Nerve Stimulation is currently in Phase 2 clinical development. It is an investigational therapy and has not yet been approved by regulatory authorities. The therapy is being studied for the treatment of epilepsy and seizure disorders, with one completed Phase 2 clinical trial.
Trigeminal Nerve Stimulation has one completed clinical trial registered under NCT01159431, titled "External Trigeminal Nerve Stimulation for Epilepsy." This Phase 2 study enrolled 50 participants in the United States and was a randomized, double-blind, controlled trial involving adults aged 18 years and older.
Trigeminal Nerve Stimulation refers to the therapy being developed by Boston Scientific Corporation for epilepsy. The completed clinical trial NCT01159431 specifically evaluated external trigeminal nerve stimulation, which is a non-invasive form of this therapy. The terms are used interchangeably in the context of this investigational treatment.