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Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Phase 2 trial testing NBI-827104 in Epileptic Encephalopathy in 19 participants. Terminated before completion.
| Lead sponsor | Neurocrine Biosciences |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 7 June 2022 |
| Primary completion | 27 January 2025 |
| Estimated completion | 27 January 2025 |
| Sites | 12 locations across Denmark, United Kingdom, Switzerland, United States, Spain |
Neurocrine Biosciences — full company profile →
Adults 4 to 12, any sex, with Epileptic Encephalopathy or Continuous Spike and Wave During Sleep. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A TEAE is an adverse event (AE) that was not present prior to the initiation of study treatment or was an already present condition that worsened either in intensity or frequency following the initiation of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| NBI-827104 | 2 |
Time frame: Up to 884 days of treatment and 4-week safety follow-up (mean duration of exposure was 649.7 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NBI-827104 |
|---|---|---|
| Osteomyelitis acute | Infections and infestations | — |
| Seizure | Nervous system disorders | — |
| Seizure cluster | Nervous system disorders | — |
| Reaction | System | NBI-827104 |
|---|---|---|
| Vomiting | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Headache | Nervous system disorders | — |
| Pyrexia | General disorders | — |
| Nasopharyngitis | Infections and infestations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Somnolence | Nervous system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Coronavirus infection | Infections and infestations | — |
| Ear infection | Infections and infestations | — |
| Gastroenteritis | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Tremor | Nervous system disorders | — |
| Aggression | Psychiatric disorders | — |
| Irritability | Psychiatric disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Ocular hyperaemia | Eye disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Gait disturbance | General disorders | — |
| Influenza like illness | General disorders | — |
| Thirst | General disorders | — |
| Conjunctivitis | Infections and infestations | — |
| Conjunctivitis bacterial | Infections and infestations | — |
| Eye infection | Infections and infestations | — |
| Helicobacter gastritis | Infections and infestations | — |
| Lymphangitis | Infections and infestations | — |
| Parainfluenzae virus infection | Infections and infestations | — |
| Pharyngitis | Infections and infestations | — |
| Pharyngitis streptococcal | Infections and infestations | — |
| Respiratory syncytial virus infection | Infections and infestations | — |
| Streptococcal infection | Infections and infestations | — |
| Tonsillitis | Infections and infestations | — |
| Viral myositis | Infections and infestations | — |
Most-reported serious reactions: Osteomyelitis acute, Seizure, Seizure cluster.
Data from ClinicalTrials.gov NCT05301894 adverse events section.
The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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