Focal Onset Seizure Clinical Trial
Official title:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects With Focal Onset Seizures (FOS)
| Verified date | September 2023 |
| Source | Neurocrine Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | August 21, 2023 |
| Est. primary completion date | August 21, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Key Inclusion Criteria: 1. Capable of providing consent and has completed the written informed consent. 2. Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^2. 3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening. 4. History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening. 5. Treatment with at least 1 but not more than 4 ASMs for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study. 6. Be able to keep accurate seizure diaries. 7. Documented seizure frequency in the baseline seizure diary of =8 countable focal seizures during the 8-week seizure baseline period. Key Exclusion Criteria: 1. History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures. 2. Presence or previous history of developmental and/or epileptic encephalopathy. 3. Presence of seizure types other than FOS. 4. History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted. 5. Status epilepticus within the last 12 months before enrollment. 6. Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt. 7. History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk. 8. A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate. 9. Require use of rescue medication more than once per week. 10. Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions. 11. An implanted responsive neurostimulator system (RNS). |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Neurocrine Clinical Site | Brisbane | Queensland |
| Australia | Neurocrine Clinical Site | Melbourne | Victoria |
| Australia | Neurocrine Clinical Site | Melbourne | Victoria |
| Australia | Neurocrine Clinical Site | Melbourne | Victoria |
| Australia | Neurocrine Clinical Site | Melbourne | Victoria |
| Australia | Neurocrine Clinical Site | Randwick | New South Wales |
| Belgium | Neurocrine Clinical Site | Bruxelles | |
| Belgium | Neurocrine Clinical Site | Gent | |
| Belgium | Neurocrine Clinical Site | Leuven | |
| Czechia | Neurocrine Clinical Site | Brno | |
| Czechia | Neurocrine Clinical Site | Ostrava | |
| Czechia | Neurocrine Clinical Site | Praha 5 | |
| Czechia | Neurocrine Clinical Site | Praha 6 | |
| Czechia | Neurocrine Clinical Site | Praha 8 | |
| Czechia | Neurocrine Clinical Site | Rychnov Nad Knežnou | |
| France | Neurocrine Clinical Site | Bron | |
| France | Neurocrine Clinical Site | Lille | |
| France | Neurocrine Clinical Site | Paris | |
| France | Neurocrine Clinical Site | Rennes | |
| France | Neurocrine Clinical Site | Toulouse | |
| Hungary | Neurocrine Clinical Site | Budapest | |
| Hungary | Neurocrine Clinical Site | Debrecen | |
| Hungary | Neurocrine Clinical Site | Kistarcsa | |
| Hungary | Neurocrine Clinical Site | Pécs | |
| Italy | Neurocrine Clinical Site | Bologna | |
| Italy | Neurocrine Clinical Site | Milano | |
| Italy | Neurocrine Clinical Site | Pavia | |
| Italy | Neurocrine Clinical Site | Pozzilli | |
| Spain | Neurocrine Clinical Site | Barcelona | |
| Spain | Neurocrine Clinical Site | Madrid | |
| Spain | Neurocrine Clinical Site | Madrid | |
| Spain | Neurocrine Clinical Site | Valencia | |
| United Kingdom | Neurocrine Clinical Site | Cardiff |
| Lead Sponsor | Collaborator |
|---|---|
| Neurocrine Biosciences |
Australia, Belgium, Czechia, France, Hungary, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs | Through Week 15 | ||
| Primary | NBI-921352 exposure-efficacy response relationship, defined as the slope of the relationship between reduction in monthly focal onset seizure frequency and plasma concentration at steady state | Baseline to Week 11 | ||
| Secondary | Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period | Baseline and Weeks 1 to 11 | ||
| Secondary | Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period | Baseline and Weeks 4 to 11 | ||
| Secondary | Clinical Global Impression of Change (CGIC) Scores at Week 11 | Week 11 | ||
| Secondary | Percentage of Participants with a = 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period | Baseline and Weeks 1 to 11 |