Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids

Reducing Dyskinesia in Parkinson Disease With Omega-3 Fatty Acids

Patrocinadores

Patrocinador principal: VA Office of Research and Development

Colaborador: Oregon Health and Science University

Fuente VA Office of Research and Development
Resumen breve

The purpose of this research study is to measure the safety (side effects) of an Omega 3 Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary movements) in Parkinson 's disease (PD).

Descripción detallada

Levodopa induced dyskinesias (LID) are involuntary, abnormal movements that occur in most patients with Parkinson disease(PD) as a consequence of chronic use of the most effective symptomatic drug, levodopa (LD). LID can range from subtle and unobtrusive to marked and disabling. There are surprisingly few treatments for LID, including amantadine and deep brain stimulation. In many instances, amantadine is either poorly tolerated, or provides inadequate benefit, and only a small minority are appropriate candidates for surgery. Given the finding that docosahexanoic acid (the most abundant omega-3 fatty acid in the brain), delays the onset and reduces the severity of dyskinesia in two different animal models of LID, a trial of docosahexanoic acid (DHA) in PD subjects about to start LD as part of their drug regimen, to prevent or slow the progression of LID is warranted.

Prior to embarking on a large trial, preliminary data about safety and tolerability of DHA in PD subjects is needed, and collection of this data is the primary outcome of this pilot project proposal. 40 subjects who have not yet used levodopa, but are about to begin it will be randomized to daily DHA or placebo. Safety laboratory testing, adverse event monitoring, DHA plasma and CSF levels as well as compliance/subject retention will be outcomes collected.

In addition, preliminary data about modification of incidence rates will be collected and compared between the two treatment groups. This information will aid in calculating an appropriate sample size and treatment period for a larger definitive future study.

Dyskinesia manifests overwhelmingly when plasma levodopa levels are high enough to cause anti-parkinsonian benefits, and lessens or stops when levodopa levels drop below a threshold. Thus, the subject's dyskinesia measurements must occur during a levodopa administration period. Dyskinesia measurement will occur during a two-hour levodopa cycle administered to subjects at weeks 0, 6, 24, 52, 76. It is expected that a good proportion of subjects will manifest dyskinesia within the two-year observation period, as previous studies using the most objective means to measure dyskinesia report incidence rates of 67% or greater within the first year of levodopa use. An instrument to measure dyskinesia developed by this center will be used as an additional outcome, and is expected to measure dyskinesia more accurately and with greater sensitivity than the gold standard methods of clinical rating scales.

By conclusion of this pilot project, the safety and tolerability, subject retention and compliance, plasma/CSF levels of DHA administration will be determined. Trends in dyskinesia development may be measured. This will provide the needed background information to proceed with a future larger trial of DHA to prevent dyskinesia in PD.

Estado general Completed
Fecha de inicio October 2012
Fecha de Terminación June 2016
Fecha de finalización primaria June 2016
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Efficacy of DHA - Change in Blood ng/dL Levels baseline and 1.5 years
Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC) Year 1
Resultado secundario
Medida Periodo de tiempo
Forceplate Measured Dyskinesia baseline and 1.5 years
Inscripción 33
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Docosahexaenoic Acid (DHA)

Descripción: Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years

Etiqueta de grupo de brazo: Arm 1

Otro nombre: DHA

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: Sugar Pill, taken for 1.5 years

Etiqueta de grupo de brazo: Arm 2

Otro nombre: Sugar Pill

Elegibilidad

Criterios:

Inclusion Criteria:

- Diagnosed with Parkinsons disease

- No levodopa (Sinemet) treatment or prior exposure to levodopa

Exclusion Criteria:

- Prior exposure to levodopa

- Unable to stand for 1 minute without aid

- Sensory deficits on feet

- Significant cognitive impairment

- Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone, tetrabenazine, metoclopramide, dronabinol)

- Current fish oil or lutein supplementation

- Allergy to soy

Género: All

Edad mínima: 21 Years

Edad máxima: 99 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Kathryn Anne Chung, MD Principal Investigator VA Portland Health Care System, Portland, OR
Ubicación
Instalaciones: VA Portland Health Care System, Portland, OR
Ubicacion Paises

United States

Fecha de verificación

May 2018

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Arm 1

Tipo: Experimental

Descripción: Docosahexaenoic Acid (DHA)

Etiqueta: Arm 2

Tipo: Placebo Comparator

Descripción: Placebo

Acrónimo RLID-PD
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Other

Enmascaramiento: Triple (Participant, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov