Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations ("Off Episodes")

Patrocinadores

Patrocinador principal: Acorda Therapeutics

Colaborador: Michael J. Fox Foundation for Parkinson's Research

Fuente Acorda Therapeutics
Resumen breve

The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

Descripción detallada

Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.

Estado general Completed
Fecha de inicio May 2012
Fecha de Terminación December 2012
Fecha de finalización primaria November 2012
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Safety change from baseline up to 13 weeks
Resultado secundario
Medida Periodo de tiempo
Pharmacodynamics 3 hours post-dose
Pharmacokinetics 3 hours post-dose
Inscripción 25
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: CVT-301

Etiqueta de grupo de brazo: CVT-301 Low Dose

Tipo de intervención: Drug

Nombre de intervención: Placebo

Etiqueta de grupo de brazo: Inhaled Placebo

Tipo de intervención: Drug

Nombre de intervención: Sinemet (carbidopa/levodopa)

Etiqueta de grupo de brazo: Oral Sinemet (carbidopa/levodopa)

Tipo de intervención: Drug

Nombre de intervención: CVT-301

Etiqueta de grupo de brazo: CVT-301 High Dose

Elegibilidad

Criterios:

Inclusion Criteria:

- Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;

- Hoehn and Yahr Stage 1-3 in an "on" state;

- Require levodopa-containing medication regimen at least 4 times during the waking day;

- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;

- Are on stable PD medication regimen.

Exclusion Criteria:

- Pregnant or lactating females;

- Previous surgery for PD or plan to have stereotactic surgery during the study period;

- History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;

- Adequate lung function as measured by spirometry;

- Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.

Género: All

Edad mínima: 30 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Civitas Clinical Site #6 | Petach-Tikva, Israel
Civitas Clinical Site #5 | Tel Aviv, Israel
Civitas Clinical Site #4 | Belgrade, Serbia
Civitas Clinical Site #7 | Belgrade, Serbia
Civitas Clinical Site #1 | Glasgow, United Kingdom
Civitas Clinical Site #3 | Newcastle, United Kingdom
Civitas Clinical Site #2 | Norwich, United Kingdom
Ubicacion Paises

Israel

Serbia

United Kingdom

Fecha de verificación

July 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: CVT-301 Low Dose

Tipo: Experimental

Descripción: CVT-Low; levodopa inhalation powder (LIP)

Etiqueta: CVT-301 High Dose

Tipo: Experimental

Descripción: CVT-High; levodopa inhalation powder (LIP)

Etiqueta: Inhaled Placebo

Tipo: Placebo Comparator

Descripción: Inhaled placebo powder

Etiqueta: Oral Sinemet (carbidopa/levodopa)

Tipo: Active Comparator

Descripción: Open-label oral carbidopa/levodopa (CD/LD)

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov