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Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Phase 3 trial testing Eslicarbazepine acetate (BIA 2-093) in Partial Epilepsy in Children and Adolescents in 304 participants. Completed in 24 August 2017.
| Lead sponsor | Bial - Portela C S.A. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 304 |
| Start date | 7 December 2007 |
| Primary completion | 20 August 2012 |
| Estimated completion | 24 August 2017 |
| Sites | 91 locations across Italy, Malaysia, Taiwan, Poland, Philippines, Croatia, Russia, Portugal |
Bial - Portela C S.A. — full company profile →
Adults 2 to 16, any sex, with Partial Epilepsy in Children and Adolescents. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 62.0 | ± 186.19 |
| Esl (BIA 2-093) | 36.6 | ± 72.47 |
Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 40 | |
| Esl (BIA 2-093) | 41 |
Time frame: from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo (Safety Set Part I) | Esl (Safety Set Part I) |
|---|---|---|---|
| PNEUMONIA | Infections and infestations | — | — |
| STATUS EPILEPTICUS | Nervous system disorders | — | — |
| DEVICE MALFUNCTION | General disorders | — | — |
| BRONCHOPNEUMONIA | Infections and infestations | — | — |
| CONVULSION | Nervous system disorders | — | — |
| VERTIGO | Ear and labyrinth disorders | — | — |
| COELIAC DISEASE | Gastrointestinal disorders | — | — |
| DRUG WITHDRAWAL SYNDROME | General disorders | — | — |
| IRRITABILITY | General disorders | — | — |
| INFECTIOUS MONONUCLEOSIS | Infections and infestations | — | — |
| VIRAL INFECTION | Infections and infestations | — | — |
| BRAIN HERNIATION | Injury, poisoning and procedural complications | — | — |
| BRAIN OEDEMA | Nervous system disorders | — | — |
| EPILEPSY | Nervous system disorders | — | — |
| GRAND MAL CONVULSION | Nervous system disorders | — | — |
| HYDROCEPHALUS | Nervous system disorders | — | — |
| HYPOTONIA | Nervous system disorders | — | — |
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | Nervous system disorders | — | — |
| ASPHYXIA | Respiratory, thoracic and mediastinal disorders | — | — |
| VASCULAR PURPURA | Skin and subcutaneous tissue disorders | — | — |
| MEDICAL DEVICE CHANGE | Surgical and medical procedures | — | — |
| Reaction | System | Placebo (Safety Set Part I) | Esl (Safety Set Part I) |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Convulsion | Nervous system disorders | — | — |
| Pyrexia | General disorders | — | — |
| Pharyngitis | Infections and infestations | — | — |
| Diplopia | Eye disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Respiratory tract infection | Infections and infestations | — | — |
| Bronchitis | Infections and infestations | — | — |
| Rhinitis | Infections and infestations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Viral infection | Infections and infestations | — | — |
| Agitation | Psychiatric disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Viral upper respiratory tract infection | Infections and infestations | — | — |
| Weight increased | Investigations | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
Most-reported serious reactions: PNEUMONIA, STATUS EPILEPTICUS, DEVICE MALFUNCTION, BRONCHOPNEUMONIA, CONVULSION, VERTIGO, COELIAC DISEASE, DRUG WITHDRAWAL SYNDROME.
Data from ClinicalTrials.gov NCT00988156 adverse events section.
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing