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Spasms, Infantile clinical trials

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NCT ID: NCT01073579 Completed - Infantile Spasms Clinical Trials

Sabril Patient Registry

Start date: August 2009
Phase: N/A
Study type: Observational

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with Sabril and the prescribers of Sabril.

NCT ID: NCT01006811 Completed - Infantile Spasms Clinical Trials

Use of the Modified Atkins Diet in Infantile Spasms

ADIS
Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).

NCT ID: NCT00968136 Completed - Infantile Spasms Clinical Trials

Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

Start date: n/a
Phase: N/A
Study type: Observational

This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.

NCT ID: NCT00552045 Completed - Epilepsy Clinical Trials

Epilepsy Phenome/Genome Project

EPGP
Start date: November 2007
Phase:
Study type: Observational

The purpose of this study is to collect detailed information about the characteristics and genetics of a large number of individuals with epilepsy.

NCT ID: NCT00441896 Completed - Infantile Spasms Clinical Trials

A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.

NCT ID: NCT00004758 Completed - Epilepsy Clinical Trials

Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

Start date: November 1993
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.

NCT ID: NCT00001325 Completed - Metabolic Disease Clinical Trials

Metabolic Abnormalities in Children With Epilepsy

Start date: April 1992
Phase: N/A
Study type: Observational

This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain. When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Researchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions; 4. Are changes in brain energy use (metabolism) present early in the course of epilepsy 5. Do changes in brain metabolism match the severity of patient's seizures 6. Do changes in metabolism occur over time or in response to drug therapy