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Also known as Ezogabine
Ezogabine/retigabine · 2 trials · 2 indications
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.
Peak plasma concentration (Cmax) of ezogabine/retigabine; and area under the plasma concentration-time curve from time zero to infinity (AUC(0-∞)) for ezogabine/retigabine
| Arm | Type | Description |
|---|---|---|
| Oral ezogabine 600 mg/day | EXPERIMENTAL | - |
| Oral ezogabine 900 mg/day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Treatment Period 1 | OTHER | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 2 | OTHER | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 3 | OTHER | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 4 | OTHER | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 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 |
| 50mg Ezogabine/retigabine | DRUG | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 100mg Ezogabine/retigabine | DRUG | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 200mg Ezogabine/retigabine | DRUG | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 400mg Ezogabine/retigabine | DRUG | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
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, also known as retigabine, is a small molecule drug developed by GSK plc (ticker: GSK). It is being studied in neurology for epilepsy and amyotrophic lateral sclerosis (ALS). It is an investigational therapy in Phase 2 development for ALS, while it has also been studied in Phase 1 for epilepsy.
Ezogabine/retigabine targets KCNQ potassium channels, specifically KCNQ1, KCNQ2, KCNQ3, KCNQ4, and KCNQ5. It acts as an opener of these channels, which are involved in regulating neuronal excitability. This mechanism underlies its investigation in neurological conditions such as epilepsy and ALS.
Ezogabine/retigabine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating this drug in epilepsy and amyotrophic lateral sclerosis.
Ezogabine/retigabine is in Phase 2 development for amyotrophic lateral sclerosis (ALS). It is investigational and has not been approved by the FDA for ALS. A Phase 1 trial in epilepsy has also been completed.
Ezogabine/retigabine has been studied in a completed Phase 2 trial, NCT02450552, titled "Clinical Trial of Ezogabine (Retigabine) in ALS Subjects." This randomized, double-blind, placebo-controlled trial enrolled 65 participants with ALS in the United States. A completed Phase 1 pharmacokinetic trial, NCT01462669, was conducted in Taiwanese subjects with epilepsy.
Yes, ezogabine and retigabine are the same drug. Ezogabine is the international nonproprietary name (INN) used in the United States, while retigabine is the name used in Europe and other regions. Both names refer to the same small molecule developed by GSK.