Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezogabine · 1 trial · 1 indication
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...
Ezogabine is an investigational small molecule being studied for epilepsy and amyotrophic lateral sclerosis (ALS). It is in Phase 2 clinical development for ALS and has completed a Phase 1 study in epilepsy. Ezogabine is not FDA approved and remains in clinical development.
Ezogabine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials of the drug in neurology indications, including epilepsy and amyotrophic lateral sclerosis.
Ezogabine is in Phase 2 clinical development for amyotrophic lateral sclerosis (ALS). It has also completed a Phase 1 study in epilepsy. The drug is investigational and not yet approved by regulatory authorities.
Ezogabine has been studied in two clinical trials. NCT01462669 was a Phase 1 crossover study in Taiwanese subjects with epilepsy, completed with 1 participant. NCT02450552 was a Phase 2 trial in ALS subjects in the United States, completed with 65 participants.
Ezogabine is also known as retigabine. Clinical trials such as NCT02450552 refer to the drug as Ezogabine (Retigabine), confirming that the two names refer to the same compound.