- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01515410
Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations
The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:
- "ON" time with no dyskinesia or non-troublesome dyskinesia
- "OFF" time
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos
-
-
Arkansas
-
Little Rock, Arkansas, Estados Unidos
-
-
California
-
Long Beach, California, Estados Unidos
-
-
Illinois
-
Chicago, Illinois, Estados Unidos
-
-
Michigan
-
Bingham Farms, Michigan, Estados Unidos
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos
-
-
Texas
-
Dallas, Texas, Estados Unidos
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
- Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
- On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
- Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
- Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
- Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
- Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.
Exclusion Criteria:
- Patients with atypical or drug-induced Parkinson's disease.
- Patients with a known history of hypersensitivity to levodopa or carbidopa.
- Patients who receive treatments with dopamine receptor blocking agents
- Patients with a history of seizures except of childhood febrile seizure.
- Patients with dementia.
- Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
- Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
- Patients with an immune-compromised state.
- Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
- Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
- Patients who have a difficulty swallowing tablets.
- Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
- Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: DM-1992
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
|
72.5mg carbidopa/230mg levodopa
|
Comparador activo: Sinemet IR
An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
|
Immediate-release tablet containing 25mg carbidopa and 100mg levodopa
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
Periodo de tiempo: Baseline and 10 days for each of the 2 study periods
|
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits. |
Baseline and 10 days for each of the 2 study periods
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rekha Sathyanarayana, Depomed
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Enfermedad de Parkinson
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Factores inmunológicos
- Agonistas de dopamina
- Agentes de dopamina
- Adyuvantes, Inmunológicos
- Agentes antiparkinsonianos
- Agentes contra la discinesia
- Combinación de fármacos carbidopa y levodopa
Otros números de identificación del estudio
- 81-0068
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre DM-1992
-
Medical College of WisconsinReclutamientoDiabetes tipo 2Estados Unidos
-
Desentum OyTerminadoAlergia al polen de abedulFinlandia
-
Desentum OyTerminadoAlergia al polen de abedulCanadá
-
Emory UniversityNational Institute of Nursing Research (NINR); Atlanta VA Medical Center; Atlanta...TerminadoInsuficiencia cardiaca | Diabetes mellitusEstados Unidos
-
National University, SingaporeTsao Foundation SingaporeActivo, no reclutandoDiabetes Mellitus, Tipo 2Singapur
-
Diabetes Foundation, IndiaMinistry of Science and Technology, IndiaAún no reclutandoDiabetes mellitus | Prediabetes | Hábito de la dieta
-
Neurovalens Ltd.R D Gardi Medical College, UjjainTerminadoProblemas de seguridadReino Unido
-
Sahlgrenska University Hospital, SwedenSuspendidoDiabetes Mellitus, Riñón, CECSuecia
-
Neurovalens Ltd.University College Dublin; Clinical Trial Mentors; CS LifescienceActivo, no reclutando
-
University of Southern CaliforniaActivo, no reclutandoDiabetes Mellitus, Tipo 2 | Diabetes Mellitus, Tipo 1Estados Unidos