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
NCT ID: NCT05159908
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2021-11-08
2023-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo schedule
Participant follows Placebo schedule (13 weeks)
Placebo
Matching placebo tablets for oral administration
Dose schedule A
Participant follows Dose schedule A (13 weeks)
NBI-921352
Tablets for oral administration
Dose schedule B
Participant follows Dose schedule B (13 weeks)
NBI-921352
Tablets for oral administration
Dose schedule C
Participant follows Dose schedule C (13 weeks)
NBI-921352
Tablets for oral administration
Interventions
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NBI-921352
Tablets for oral administration
Placebo
Matching placebo tablets for oral administration
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
2. Presence or previous history of developmental and/or epileptic encephalopathy.
3. Presence of seizure types other than FOS.
4. Status epilepticus within the last 12 months before enrollment.
5. 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.
6. Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
7. An implanted responsive neurostimulator system (RNS).
18 Years
65 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Randwick, New South Wales, Australia
Neurocrine Clinical Site
Ivanhoe, Victoria, Australia
Neurocrine Clinical Site
Melbourne, Victoria, Australia
Neurocrine Clinical Site
Parkville, Victoria, Australia
Neurocrine Clinical Site
Prahran, Victoria, Australia
Neurocrine Clinical Site
Brussels, , Belgium
Neurocrine Clinical Site
Ghent, , Belgium
Neurocrine Clinical Site
Leuven, , Belgium
Neurocrine Clinical Site
Brno, , Czechia
Neurocrine Clinical Site
Ostrava, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Prague, , Czechia
Neurocrine Clinical Site
Rychnov nad Kněžnou, , Czechia
Neurocrine Clinical Site
Bron, , France
Neurocrine Clinical Site
Lille, , France
Neurocrine Clinical Site
Rennes, , France
Neurocrine Clinical Site
Toulouse, , France
Neurocrine Clinical Site
Budapest, , Hungary
Neurocrine Clinical Site
Debrecen, , Hungary
Neurocrine Clinical Site
Pécs, , Hungary
Neurocrine Clinical Site
Bologna, , Italy
Neurocrine Clinical Site
Milan, , Italy
Neurocrine Clinical Site
Pavia, , Italy
Neurocrine Clinical Site
Barcelona, , Spain
Neurocrine Clinical Site
Madrid, , Spain
Neurocrine Clinical Site
Madrid, , Spain
Neurocrine Clinical Site
Valencia, , Spain
Countries
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Other Identifiers
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2021-001433-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NBI-921352-FOS2021
Identifier Type: -
Identifier Source: org_study_id
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