Katherine C. Nickels, M.D.

Closed for Enrollment

• A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus (RAISE) Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to establish the effectiveness and safety of IV ganaxolone for the treatment of Status Epilepticus (SE) after failure of first-line benzodiazepines and two second-line IV antiepileptic drugs (AEDs)

• A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy Rochester, Minn.

  This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).

• A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients Rochester, Minn.

  The purpose of this study is to allow JBPOS0101 (investigational product) to be given as either add-on therapy or monotherapy for patients with refractory infantile spasms. 

• A Randomized, Double-blind, Placebo-controlled, Multisite, Phase 3 Study to Investigate the Efficacy and Safety of Cannabidiol Oral Solution (GWP42003-P) in Children and Adolescents With Epilepsy With Myoclonic-Atonic Seizures Rochester, Minn.

  The primary aim of Part A of the study to assess the effectiveness and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures. Part B of this study will be conducted to evaluate the long-term safety and tolerability of GWP42003-P in participants with EMAS.

• A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-Label Extension Trial to Assess Long-Term Safety of ZX008 in Children and Adults With LGS Rochester, Minn.

  This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

• ENVISION: Natural History Study of Infants and Children with SCN1A-positive Dravet Syndrome (ENVISION) Rochester, Minn.

  The purpose of this study is to characterize the phenotype of SCN1A-positive Dravet Syndrome in subjects aged 6 to 60 months, inclusive.

• Non-Inferiority Prospective Randomized Trial of Acetazolamide versus Diazepam in Patients with Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS) Rochester, Minn.

  The purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam for the treatment of patients who have continuous spike wave brain pattern in sleep or Landau-Kleffner syndrome.

• Phase I, Open-Label, Single-Center Study Evaluating the Safety and Efficacy of Fenfluramine Hydrochloride Oral Solution, ZX008, as Adjunctive Therapy in Children with Intractable Epilepsy with Myoclonic-Atonic Seizures (Doose Syndrome) (ZX008) Rochester, Minn.

  The purpose of this study is to document the effectiveness of  ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008 compared with baseline.

• Single-Center, Open-Label Extension Study Evaluating the Safety and Efficacy of Fenfluramine Hydrochloride Oral Solution, ZX008, as Adjunctive Therapy in Children with Intractable Epilepsy with Myoclonic-Atonic Seizures (Doose Syndrome) (ZX008) Rochester, Minn.

  The purpose of this study is to document the effectiveness of ZX008 as adjunctive therapy by documenting percent reduction in convulsive seizures and drop seizures in subjects taking ZX008compared to baseline.