Levetiracetam Treatment of L-dopa Induced Dyskinesias
Colección de datos
Sinucleinopatías+5
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades de los Ganglios Basales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2004
Fecha en la que se inscribió al primer participante.Introduction: Parkinson's disease is a progressive degenerative disease of unknown etiology. Its treatment has been symptomatic and the most successful approach has been to replace the missing dopamine through administration of its precursor levodopa. As the disease progresses the usefulness of this approach gradually diminishes and motor complications become a source of significant disability. Although a number of pharmacological strategies have attempted to improve this situation, none has yet proven fully satisfactory. The mechanism by which levetiracetam exerts this beneficial effect is unknown. Recently, in a PD monkey model levetiracetam was found to moderate dyskinesias and other motor complications, possibly due to its effects on striatal GABAergic transmission. Objective: To evaluate the acute ability of levetiracetam to safely ameliorate dopaminomimetic-treatment-associated dyskinesias and related motor complications in parkinsonian patients without compromising the antiparkinsonian response. Study Population: 22 moderately advanced parkinsonian patients will be enrolled into a randomized, placebo controlled, double-blind proof-of-principle study. Levetiracetam efficacy will be assessed through the use of validated motor function scales. Safety will be monitored by means of frequent clinical evaluations and laboratory tests. Anticipated Risks and Benefits: The potential risks associated with this study amount to only a minor increase over minimal risk and are primarily associated with adverse reactions to the medications involved. Levetiracetam is a marketed drug with a wide margin of safety. Patients receiving drug could benefit from improvement of their symptoms, those on placebo will also have their medications adjusted, leading to an improved quality of life. Outcome Estimate and Potential Meaning for the Field: This study should further the understanding of mechanisms contributing to motor disability in patients with PD that may lead to the development of improved therapeutic interventions for this disorder and for associated motor response complications.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
INCLUSION CRITERIA: Patients who meet all of the following inclusion criteria will be able to participate in the study: 1. Patient is between the ages of 30 and 80, inclusive; 2. Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurological findings; 3. Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations ; 4. Patient is willing to adhere to protocol requirements as evidenced by written, informed consent. EXCLUSION CRITERIA: Patients meeting any of the following exclusion criteria will not be enrolled or immediately withdrawn from the study, as appropriate: 1. Patient has a history of any medical condition that can reasonably be expected to subject them to unwaranted risk; 2. Patient has clinically significant laboratory abnormalities including impaired renal function (CL(cr) equals 30-50 ml/min.); 3. Patient is uable to br treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipexole or ropinirole; 4. Patient is taking a prohibited concomitant medication; 5. Patient has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal (if female); 6. Patient is pregnant or breastfeeding; 7. Patient is implanted with bilateral deep brain stimulators; 8. Patient has prior pallidotomy or other ablative surgeries for treatment of PD; 9. Patient has cognitive impairment (MMSE less than 25); 10. Patient has participated in a clinical study with an investigational drug within the last 30 days; 11. Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety; 12. Patient is unwilling to sign an informed consent or to comply with protocol requirements; 13. Patient has a history of psychiatric illness.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación