Focal Onset SeizurePhase 2NCT05159908
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
A Phase 2 study testing NBI-921352 in people with Focal Onset Seizure and Focal Onset Epilepsy, run by Neurocrine Biosciences at 28 sites in 7 countries.
Trial summary
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Onset Seizure, Focal Onset Epilepsy
- What is being tested?
- NBI-921352
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 8 Nov 2021to 21 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of providing consent and has completed the written informed consent.
- Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^2.
- Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
- History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
- 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.
- Be able to keep accurate seizure diaries.
- Documented seizure frequency in the baseline seizure diary of ≥8 countable focal seizures during the 8-week seizure baseline period.
Who cannot join
- History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
- Presence or previous history of developmental and/or epileptic encephalopathy.
- Presence of seizure types other than FOS.
- Status epilepticus within the last 12 months before enrollment.
- 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.
- Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- An implanted responsive neurostimulator system (RNS).
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
Czechia6 sites
Neurocrine Clinical Site
Brno, 656 91
Neurocrine Clinical Site
Ostrava, 708 52
Neurocrine Clinical Site
Prague, 150 06
Neurocrine Clinical Site
Prague, 160 00
Neurocrine Clinical Site
Prague, 186 00
Neurocrine Clinical Site
Rychnov nad Kněžnou, 516 01
Australia5 sites
Neurocrine Clinical Site
Ivanhoe, Victoria, 3079
Neurocrine Clinical Site
Melbourne, Victoria, 3065
Neurocrine Clinical Site
Parkville, Victoria, 3050
Neurocrine Clinical Site
Prahran, Victoria, 3181
Neurocrine Clinical Site
Randwick, New South Wales, 2031
France4 sites
Neurocrine Clinical Site
Bron, 69677
Neurocrine Clinical Site
Lille, 59037
Neurocrine Clinical Site
Rennes, 35033
Neurocrine Clinical Site
Toulouse, 31059
Spain4 sites
Neurocrine Clinical Site
Barcelona, 08035
Neurocrine Clinical Site
Madrid, 28034
Neurocrine Clinical Site
Madrid, 28040
Neurocrine Clinical Site
Valencia, 46026
Belgium3 sites
Neurocrine Clinical Site
Brussels, 1070
Neurocrine Clinical Site
Ghent, 9000
Neurocrine Clinical Site
Leuven, 3000
Hungary3 sites
Neurocrine Clinical Site
Budapest, 1145
Neurocrine Clinical Site
Debrecen, 4032
Neurocrine Clinical Site
Pécs, 7623
Italy3 sites
Neurocrine Clinical Site
Bologna, 40139
Neurocrine Clinical Site
Milan, 20133
Neurocrine Clinical Site
Pavia, 27100
About this study
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)
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
- Conditions
- Focal Onset Seizure, Focal Onset Epilepsy
- Being tested
- NBI-921352, Placebo
- Keywords
- Epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, Antiseizure medication, ASM, Antiepileptic drug, AED, partial seizure, partial onset epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-921352Drug
Tablets for oral administration
PlaceboDrug
Matching placebo tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo schedule | Placebo comparator | Participant follows Placebo schedule (13 weeks) Receives: Drug: Placebo |
| Dose schedule A | Experimental | Participant follows Dose schedule A (13 weeks) Receives: Drug: NBI-921352 |
| Dose schedule B | Experimental | Participant follows Dose schedule B (13 weeks) Receives: Drug: NBI-921352 |
| Dose schedule C | Experimental | Participant follows Dose schedule C (13 weeks) Receives: Drug: NBI-921352 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
Measured: Through Week 15
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
Measured: Baseline to Week 11
Secondary outcomes (4)
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period
Measured: Baseline and Weeks 1 to 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period
Measured: Baseline and Weeks 4 to 11
Clinical Global Impression of Change (CGIC) Scores at Week 11
Measured: Week 11
Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period
Measured: Baseline and Weeks 1 to 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start8 Nov 2021
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizureStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159908
- Sponsor's protocol ID
- NBI-921352-FOS2021
- Other IDs
- 2021-001433-39
- Status last verified
- Sep 2024
- First submitted
- 30 Nov 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05159908
- Acronym / sponsor ID
- NBI-921352-FOS2021
- Conditions
- Focal Onset Seizure, Focal Onset Epilepsy
- Keywords
- Epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, Antiseizure medication, ASM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo schedule | Placebo comparator | Drug: PlaceboParticipant follows Placebo schedule (13 weeks) |
| Dose schedule A | Experimental | Drug: NBI-921352Participant follows Dose schedule A (13 weeks) |
| Dose schedule B | Experimental | Drug: NBI-921352Participant follows Dose schedule B (13 weeks) |
| Dose schedule C | Experimental | Drug: NBI-921352Participant follows Dose schedule C (13 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of providing consent and has completed the written informed consent.
- Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^2.
- Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
- History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
- 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.
Key exclusion criteria (7 listed)
- History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
- Presence or previous history of developmental and/or epileptic encephalopathy.
- Presence of seizure types other than FOS.
- Status epilepticus within the last 12 months before enrollment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-921352Tablets for oral administration | Drug | Dose schedule A, Dose schedule B, Dose schedule C |
| PlaceboMatching placebo tablets for oral administration | Drug | Placebo schedule |
Primary outcome
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
Time frame: Through Week 15
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
Time frame: Baseline to Week 11
4 secondary outcomes
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period
Time frame: Baseline and Weeks 1 to 11
Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period
Time frame: Baseline and Weeks 4 to 11
Clinical Global Impression of Change (CGIC) Scores at Week 11
Time frame: Week 11
Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period
Time frame: Baseline and Weeks 1 to 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Focal Onset Seizure
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
RecruitingPhase 3
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Focal Onset Seizures
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-921352 in people with Focal Onset Seizure and Focal Onset Epilepsy, run by Neurocrine Biosciences at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Czechia, Australia, France, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs (time frame: Through Week 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.