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 being studied for the treatment of Essential Tremor and Epileptic Encephalopathy, specifically Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep. It is in Phase 2 clinical development and is not yet approved by the FDA.
NBI-827104 is a small molecule developed by Neurocrine Biosciences. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential to treat neurological conditions including Essential Tremor and Epileptic Encephalopathy.
NBI-827104 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in neurological indications.
NBI-827104 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials have been completed, one in pediatric patients with Epileptic Encephalopathy and one in adults with Essential Tremor.
NBI-827104 has completed two Phase 2 clinical trials. NCT04625101 studied the drug in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep, enrolling 24 participants. NCT04880616 studied the drug for Essential Tremor in 31 adult participants. Both trials are completed.
NBI-827104 is the primary name used for this investigational compound. No alternative names have been reported in clinical trial registrations. It is a distinct small molecule being developed by Neurocrine Biosciences for neurological conditions.