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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 21, 2014
Last verified: October 2014

March 16, 2012
October 21, 2014
October 2012
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01563913 on ClinicalTrials.gov Archive Site
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.
Dyskinesia [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Dyskiensia are abnormal movements caused by levodopa. These abnormal movements will be measured with a forceplate (a device that is similiar 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.
Not Provided
Not Provided
 
Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
Reducing Dyskinesia in Parkinson Disease With Omega-3 Fatty Acids

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Parkinson's Disease
  • Drug: Docosahexaenoic Acid (DHA)
    Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
    Other Name: DHA
  • Drug: Placebo
    Sugar Pill, taken for 1.5 years
    Other Name: Sugar Pill
  • Experimental: Arm 1
    Docosahexaenoic Acid (DHA)
    Intervention: Drug: Docosahexaenoic Acid (DHA)
  • Placebo Comparator: Arm 2
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
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
United States
 
NCT01563913
CLIN-006-11S, 2907, 8012
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Oregon Health and Science University
Principal Investigator: Kathryn Anne Chung, MD VA Medical Center, Portland
Department of Veterans Affairs
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP