Treatment will consist of KD will consist of 3:1 [fat]: [protein + carbohydrate] weight ratio, with 1600 kcal restriction for patients with body mass index (BMI) of ≥ 21. The diet will be initiated with a 24 hour fast to induce ketosis. The diet will be supplemented with vitamins, calcium and phosphorus supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard. If seizure frequency does not improve after 3 months of KD treatment, [fat]: [protein + carbohydrate] weight ratio will be increased to 4:1

Epilepsy

KD will consist of 3:1 [fat]: [protein + carbohydrate] weight ratio, with 1600 kcal restriction

ketogenic diet

MidAtlantic Epilepsy and Sleep Center

Efficacy and Safety of Ketogenic Diet as Adjunctive Treatment in Adults With Refractory Epilepsy

Evaluation of the Efficacy and Safety of Ketogenic Diet as Adjunctive Treatment in Adults With Refractory Epilepsy: a Pilot Study.

Seizure frequency, adverse events and treatment compliance will be reviewed. The diet will be reviewed with the subject by the nutritionist before treatment initiation. Seizure frequency will be counted using a daily seizure diary. Subject's neurological and other clinical progress since the last visit will be reviewed. Concurrent medications will be documented. Vital signs and weight will be obtained, and a complete physical and neurological examination will be performed. Body mass index will be calculated. Subjects seizure/urine ketone diary will be reviewed at each visit.
Treatment compliance will be evaluated with urine ketone levels using the diaries and with serum b-hydroxy-butyrate (b-OH-butyrate, BOH) levels.

Adverse events and treatment compliance will be reviewed.Subject's neurological and other clinical progress since the last visit will be reviewed.

Quality of life will be evaluated with a standardized questionnaire of quality of life in patients with epilepsy, QOLIE-31-P.

Alertness will be evaluated with Epworth Sleepiness Scale.

Pavel Klein

Mid-Atlantic Epilepsy and Sleep Center, LLC

Two capsules (one Org 24448 250 mg capsule and one placebo capsule that is identical to the active treatment) will be ingested orally daily for eight weeks.

Two capsules (two Org 24448 250 mg capsules) will be ingested orally daily for eight weeks.

Two capsules (two placebo capsules that are identical to the active treatment) will be ingested orally daily for eight weeks.

Schizophrenia

Org 24448 is a moderate-potency selective AMPA positive modulator that enhances the glutamate system in the brain.

Org 24448

Placebo

UCLA

Maryland Psychiatric Research Center

Massachusetts General Hospital

Harvard Medical School

Washington University School of Medicine

Columbia University Medical Center

Nathan Kline Institute

Duke University Medical Center

Org 24448 (Ampakine) for Cognitive Deficits in Schizophrenia

A Placebo-Controlled Trial of Org 24448 (Ampakine) Added to Atypical Antipsychotics in Patients With Schizophrenia

The MATRICS Consensus Cognitive Battery assesses cognitive function in the following domains: speed of processing, attention/vigilance, verbal learning, visual learning, reasoning and problem solving, and social cognition.

The UPSA assesses skills necessary for functioning in the community by asking patients to perform relevant tasks, rating their performance in five areas: household chores, communication, finance, transportation, and planning recreational activities.

The SCoRS is an assessment of cognitive deficits and the degree to which they affect day-to-day functioning. The items assess the cognitive domains of attention, memory, reasoning and problem solving, working memory, processing speed, language functions, and social cognition.

calcium phosphate/seizures

Efficacy and Safety of Ketogenic Diet as Adjunctive Treatment in Adults With Refractory Epilepsy

Org 24448 (Ampakine) for Cognitive Deficits in Schizophrenia

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