Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01159431 | External Trigeminal Nerve Stimulation for Epilepsy | PHASE2 | COMPLETED | 50 | — | — | Jan 1, 2008 | Jun 1, 2011 | Jun 3, 2013 | 2 | United States |
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...