Focal Onset SeizurePhase 2NCT05493293
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 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 26 sites in 7 countries.
Trial summary
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study… Read more about this study
- Who is it for?
- Ages 18 to 67 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?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 26 sitesin 7 countries
- Study dates
- 9 Nov 2022to 11 Mar 2024
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided informed consent.
- Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
- Stable treatment with at least 1 but not more than 4 antiseizure medicines.
Who cannot join
- Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
Czechia6 sites
Neurocrine Clinical Site
Brno, 65691
Neurocrine Clinical Site
Ostrava, 708 52
Neurocrine Clinical Site
Prague, 15006
Neurocrine Clinical Site
Prague, 16000
Neurocrine Clinical Site
Prague, 18600
Neurocrine Clinical Site
Rychnov nad Kněžnou, 51601
France4 sites
Neurocrine Clinical Site
Bron, 69677
Neurocrine Clinical Site
Lille, 59037
Neurocrine Clinical Site
Rennes, 35000
Neurocrine Clinical Site
Toulouse, 31059
Spain4 sites
Neurocrine Clinical Site
Barcelona, 8035
Neurocrine Clinical Site
Madrid, 28034
Neurocrine Clinical Site
Madrid, 28040
Neurocrine Clinical Site
Valencia, 46026
Australia3 sites
Neurocrine Clinical Site
Fitzroy, 3065
Neurocrine Clinical Site
Heidelberg, 3084
Neurocrine Clinical Site
Melbourne, 3004
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
Budapest, 40320
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: Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
- Conditions
- Focal Onset Seizure, Focal Onset Epilepsy
- Being tested
- NBI-921352
- Keywords
- epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, antiseizure medicine, 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
| Study group | Role | What they receive |
|---|---|---|
| NBI-921352 Treatment | Experimental | Treatment for up to 107 weeks. Receives: Drug: NBI-921352 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of serious treatment-emergent adverse events (TEAEs)
Measured: Through Week 111
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start9 Nov 2022
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Why it stopped: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT05493293
- Sponsor's protocol ID
- NBI-921352-FOS2022
- Other IDs
- 2021-004265-12
- Status last verified
- Apr 2024
- First submitted
- 5 Aug 2022
- Last updated
- 12 Apr 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)
- ClinicalTrials.gov ID
- NCT05493293
- Acronym / sponsor ID
- NBI-921352-FOS2022
- Conditions
- Focal Onset Seizure, Focal Onset Epilepsy
- Keywords
- epilepsy, focal seizure, sodium channel, voltage-gated, alpha subunit, Nav1.6 inhibitor, antiseizure medicine, ASM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 9 Aug 2022 (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 Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBI-921352 Treatment | Experimental | Drug: NBI-921352Treatment for up to 107 weeks. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provided informed consent.
- Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
- Stable treatment with at least 1 but not more than 4 antiseizure medicines.
Key exclusion criteria (1 listed)
- Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.
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 | NBI-921352 Treatment |
Primary outcome
The occurrence of serious treatment-emergent adverse events (TEAEs)
Time frame: Through Week 111
Results and safety
The study was stopped early (reason given: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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RecruitingPhase 3
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Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
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
26 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 26 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Czechia, France, Spain, Australia, 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. 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 was stopped early (reason given: The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.). Results are not available in the source record.
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?
The occurrence of serious treatment-emergent adverse events (TEAEs) (time frame: Through Week 111). 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 12 Apr 2024.