Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids (RLID-PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01563913
First received: March 16, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Drug: Docosahexaenoic Acid (DHA)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Reducing Dyskinesia in Parkinson Disease With Omega-3 Fatty Acids

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Safety/Efficacy of DHA [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    This study is seeking to determine the safety/efficacy of DHA in Parkinson's disease patients. The safety/efficacy of DHA will be determined using adverse event monitoring, periodic safety lab information, monthly telephone calls, therapeutic level monitoring, and assessment of dietary intakes. Adverse event monitoring will be accomplished with interviewing on the telephone and in person visits. Safety lab information and therapeutic level monitoring will be accomplished by analyzing blood levels for DHA.


Secondary Outcome Measures:
  • Dyskinesia [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    Dyskinesia are abnormal movements caused by levodopa. These abnormal movements will be measured with a forceplate (a device that is similar to a door mat). Dyskinesia will be examined at all inpatient visits and area under the curves will be compared with a clinical rating scale to measure the development of dyskinesia after starting levodopa therapy.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Docosahexaenoic Acid (DHA)
Drug: Docosahexaenoic Acid (DHA)
Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
Other Name: DHA
Placebo Comparator: Arm 2
Placebo
Drug: Placebo
Sugar Pill, taken for 1.5 years
Other Name: Sugar Pill

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563913

Contacts
Contact: Brenna M Lobb (503) 220-8262 ext 51871 Brenna.Lobb@va.gov
Contact: Susan O'Connor, RN (503) 220-8262 ext 53262 Susan.OConnor2@va.gov

Locations
United States, Oregon
VA Medical Center, Portland Recruiting
Portland, Oregon, United States, 97201
Contact: Brenna M Lobb    (503) 220-8262 ext 51871    Brenna.Lobb@va.gov   
Contact: Susan O'Connor, RN    (503) 220-8262 ext 53262    Susan.OConnor2@va.gov   
Principal Investigator: Kathryn Anne Chung, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Kathryn Anne Chung, MD VA Medical Center, Portland
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01563913     History of Changes
Other Study ID Numbers: CLIN-006-11S, 2907, 8012
Study First Received: March 16, 2012
Last Updated: May 6, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Parkinsons disease
supplement
DHA
dyskinesia
abnormal movements

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 21, 2014