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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006191
Effect of Levetiracetam on Brain Excitability
Effects of Levetiracetam on Cortical Excitability in Humans
This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new protection mechanism against seizures as well as the effect of the drug on cortical excitability.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates will have a medical history taken and undergo physical and neurological examinations.
Participants will undergo two different procedures in four separate sessions. One procedure (cortical excitability) involves taking either levetiracetam or placebo (a look-alike inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very brief electrical current is passed through an insulated coil wire placed on the scalp. The magnetic pulse travels through the scalp and skull, causing small electrical currents in the cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. Electrical activity of the muscles will be recorded using electrodes taped to the skin over the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of a metronome every two seconds and then completely relaxes the hand until the next beat.
Subjects will be tested on four different days at least 72 hours apart. Each session will last about 3 to 4 hours.
Approximate schedule for cortical excitability testing:
TMS (study 1)
Take levetiracetam or placebo
TMS (study 2) < 60 minutes after drug or placebo
TMS (study 3) < 120 minutes after drug or placebo
Approximate schedule for pinch-training related changes:
Take levetiracetam or placebo
TMS and pinch power measurement < 60 minutes after drug or placebo
Pinch training for 30 minutes
TMS and pinch power measurement
Sample schedule:
Session 1 < LTC and cortical excitability testing
Session 2 < Placebo and cortical excitability testing
Session 3 < LTC and pinch-training related changes
Session 4 < Placebo and pinch-training related changes
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
This study will be done on normal volunteers.
Subjects will be adults older than age 18.
No development of a serious medical condition.
Compliance with protocol evaluations or examinations.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV). Epilepsy Res. 1999 Mar;34(1):1-41. doi: 10.1016/s0920-1211(98)00108-9.
- Wulfert E, Hanin I, Verloes R. Facilitation of calcium-dependent cholinergic function by ucb L059, a new "second generation" nootropic agent. Psychopharmacol Bull. 1989;25(3):498-502.
- Loscher W, Honack D. Profile of ucb L059, a novel anticonvulsant drug, in models of partial and generalized epilepsy in mice and rats. Eur J Pharmacol. 1993 Mar 2;232(2-3):147-58. doi: 10.1016/0014-2999(93)90768-d.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 000207
- 00-N-0207
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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