Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NBI-827104 · 2 trials · 3 indications
The ratio of SWI at the end of Week 6 to baseline during the first hour (60 minutes) of NREM sleep based on centralized video-electroencephalograph (EEG) reading using a log base 10 scale. Baseline was defined as the last value measured prior to intake of study treatment on Day 1. SWI was defined as the percentage of seconds with ≥1 spike-wave complex(es) during defined periods of overnight NREM sleep.
| Arm | Type | Description |
|---|---|---|
| NBI-827104 | EXPERIMENTAL | NBI-827104 administered orally for 13 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally for 13 weeks. |
| Sequence 1 | EXPERIMENTAL | In treatment period 1 participants will receive increasing doses of NBI-827104 for 28 days. After a 14-day washout period, participants will receive matching placebo for 28 days in treatment period 2. |
| Sequence 2 | EXPERIMENTAL | In treatment period 1 participants will receive matching placebo for 28 days. After a 14-day washout period, participants will receive increasing doses of NBI-827104 for 28 days in treatment period 2. |
| Name | Type | Description |
|---|---|---|
| NBI-827104 | DRUG | Triple T-type calcium channel blocker. |
| Placebo | DRUG | Non-active dosage form. |
Inclusion Criteria: 1. Signed informed consent by the parent(s) or legal representative(s) and, if applicable, assent from developmentally capable pediatric subjects. 2. Diagnosis of EECSWS. 3. Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP). 4. Stable dosage and stable...
NBI-827104 is an investigational small molecule developed by Neurocrine Biosciences, Inc. (ticker NBIX) for neurological conditions. It has been studied in clinical trials for essential tremor and for epileptic encephalopathy with continuous spike-and-wave during sleep. It is a Phase 2 candidate and is not approved for any indication.
NBI-827104 has been studied for essential tremor and for epileptic encephalopathy with continuous spike-and-wave during sleep. Both are neurological conditions. The drug remains investigational, and its use is limited to clinical research settings rather than routine clinical care.
NBI-827104 targets the T-type calcium channel, a type of ion channel. T-type calcium channels help regulate neuronal excitability and rhythmic firing in the brain, which is why blocking them is being explored in neurological conditions such as essential tremor and epileptic encephalopathy.
NBI-827104 is being developed by Neurocrine Biosciences, Inc., which trades under the ticker NBIX. The company is the sponsor of the clinical program studying the compound in neurological indications, including essential tremor and epileptic encephalopathy with continuous spike-and-wave during sleep.
NBI-827104 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA for any indication. Its clinical program consists of completed Phase 2 trials rather than any ongoing registrational studies.
NBI-827104 has been evaluated in two completed Phase 2 trials. NCT04880616 studied the safety, efficacy, and tolerability of NBI-827104 in adults with essential tremor in the Netherlands. NCT04625101 studied efficacy, safety, tolerability, and pharmacokinetics in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep across the United States, Canada, Denmark, Spain, Switzerland, and the United Kingdom.