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Clinical Studies
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Epilepsy Genetic Database
Rochester, Minn.
The purpose of this study is to develop a centralized national database of common and rare genetic etiologies of childhood-onset epilepsy
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Parental and child perceptions of anxiety and depression in children with epilepsy
Rochester, Minn.
This study aims to assess the level of anxiety and depression in children with epilepsy and compare to the level of anxiety and depression perceived by family by using validated, standardized measures as both comorbid conditions can significantly impact both quality of life and disease course.
Closed for Enrollment
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A Multicenter, Open-Label, Randomized, Active Comparator Study To Evaluate The Efficacy, Safety And Pharmacokinetics Of Lacosamide In Neonates With Repeated Electroencephalographic Neonatal Seizures
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness of Lacosamide (LCM) vs. an Active Comparator chosen based on Standard-of-Care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
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Effects Of N-Acetyl-L-Leucine On Niemann-Pick Disease Type C (NPC): A Phase III, Randomized, Placebo-controlled, Double-blind, Crossover Study
Rochester, Minn.
The purpose of this study is to demonstrate that N-Acetyl-L-Leucine is effective in improving symptoms, functioning, and quality of life against the defined endpoints in patients with Niemann-Pick Disease Type C (NPC) for the purpose of establishing the benefit/risk balance of the investigational medicinal product (IB1001) in the proposed clinical setting.
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Long-Term, Open-Label Extension Study To Evaluate The Safety And Tolerability Of NBI-827104 In Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Rochester, Minn.
The primary objective of this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric subjects with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS) when administered for up to 106 weeks.
Its secondary objectives are to investigate the effect of NBI-827104 on the overnight epileptiform video-electroeItephalogram (video-EEG) activity in pediatric subjects with EECSWS, and to investigate the long-term effect of NBI-827104 on the symptoms of EECSWS, including sleep and cognition, in pediatric subjects.
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Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy, Safety, Tolerability, And Pharmacokinetics Of NBI-827104 In Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
Rochester, Minn.
The purposes of this research are to assess the effect of NBI-827104, compared with placebo (no active drug), on the overnight epileptiform electroencephalogram (EEG) activity in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS), to evaluate the safety and tolerability of multiple doses of NBI-827104 in pediatric participants with EECSWS, and to evaluate the effect of NBI-827104 on sleep and on cognition in pediatric participants with EECSWS.
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