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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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.

Country

City, postcode or hospital

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

Other trials in Czechia

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

Other trials in Australia

France4 sites

Neurocrine Clinical Site
Bron, 69677
Neurocrine Clinical Site
Lille, 59037
Neurocrine Clinical Site
Rennes, 35033
Neurocrine Clinical Site
Toulouse, 31059

Other trials in France

Spain4 sites

Neurocrine Clinical Site
Barcelona, 08035
Neurocrine Clinical Site
Madrid, 28034
Neurocrine Clinical Site
Madrid, 28040
Neurocrine Clinical Site
Valencia, 46026

Other trials in Spain

Belgium3 sites

Neurocrine Clinical Site
Brussels, 1070
Neurocrine Clinical Site
Ghent, 9000
Neurocrine Clinical Site
Leuven, 3000

Other trials in Belgium

Hungary3 sites

Neurocrine Clinical Site
Budapest, 1145
Neurocrine Clinical Site
Debrecen, 4032
Neurocrine Clinical Site
Pécs, 7623

Other trials in Hungary

Italy3 sites

Neurocrine Clinical Site
Bologna, 40139
Neurocrine Clinical Site
Milan, 20133
Neurocrine Clinical Site
Pavia, 27100

Other trials in Italy

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 groups in NCT05159908
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.

8 Nov 202121 Aug 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Prospective Study of Eslicarbazepine in Adults With Focal-Onset Seizures
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Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
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