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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02450552 | Clinical Trial of Ezogabine (Retigabine) in ALS Subjects | PHASE2 | COMPLETED | 65 | — | — | Jun 1, 2015 | Feb 1, 2018 | Aug 28, 2019 | 12 | United States |
Short-interval intracortical inhibition (SICI) or paired-pulse SICI is defined as the ratio of the response after a conditioning pulse equal to 80% of resting motor threshold (RMT) is administered 3 ms prior to the signaling pulse divided by motor evoked potential (MEP) amplitude. Transcranial magnetic stimulation (TMS) is a neurophysiologic test for assessing upper motor neuron function. Change in SICI will be assessed by transcranial magnetic stimulation (TMS) after treatment with 900 mg/day or 600 mg/day of ezogabine vs. matched oral placebo.
| Arm | Type | Description |
|---|---|---|
| Oral ezogabine 600 mg/day | EXPERIMENTAL | - |
| Oral ezogabine 900 mg/day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ezogabine | DRUG | Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments. |
| Placebo | DRUG | Matched placebo |
ALS Subject Inclusion Criteria: * Male or female, aged 18 to 80. * Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria. * Slow vital capacity (SVC) measure ≥ 50% of predicted for gender, height and age at th...