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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 (IB1001-301 NPC)
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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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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Pilot study on the use of a wearable remote electroencephalography device to identify neonates at risk for neonatal seizures and status epilepticus (RENS)
Rochester, Minn.
The purpose of this study is to pilot the use of a remote electroencephalography (EEG) tool in neonates who are at increased risk for seizure. This will be used to assess the need for initiation of formal EEG, as well as, the need to escalate care in at risk neonates. This will be trialed in neonates who are demonstrating signs at birth of mild neonatal encephalopathy, as determined clinically by the neonatologist.
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 (LENS)
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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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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