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

NCT01563913 | Completed Phase 1 Results DMC

• 3 other identifiers: CLIN-006-11S29078012
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Parkinson's Disease

Keywords

Parkinsons disease; supplement; DHA; dyskinesia; abnormal movements

Outcome Measures

Primary Outcomes (2)

• Efficacy of DHA - Change in Blood ng/dL Levels

  Therapeutic level monitoring will be accomplished by analyzing blood levels for DHA.

  baseline and 1.5 years

• Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)

  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 periodic safety lab information. Safety labs for complete blood count (CBC) were performed at each inpatient visit, reviewed by the PI, and marked as normal or abnormal.

  Year 1

Secondary Outcomes (1)

• Forceplate Measured Dyskinesia

  baseline and 1.5 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Docosahexaenoic Acid (DHA)

Drug: Docosahexaenoic Acid (DHA)

Arm 2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Docosahexaenoic Acid (DHA) DRUG

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

Also known as: DHA

Arm 1

Placebo DRUG

Sugar Pill, taken for 1.5 years

Also known as: Sugar Pill

Arm 2

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Parkinsons disease
• No levodopa (Sinemet) treatment or prior exposure to levodopa

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (5)

• Salem N Jr, Litman B, Kim HY, Gawrisch K. Mechanisms of action of docosahexaenoic acid in the nervous system. Lipids. 2001 Sep;36(9):945-59. doi: 10.1007/s11745-001-0805-6.

  PMID: 11724467 BACKGROUND

• Pechevis M, Clarke CE, Vieregge P, Khoshnood B, Deschaseaux-Voinet C, Berdeaux G, Ziegler M; Trial Study Group. Effects of dyskinesias in Parkinson's disease on quality of life and health-related costs: a prospective European study. Eur J Neurol. 2005 Dec;12(12):956-63. doi: 10.1111/j.1468-1331.2005.01096.x.

  PMID: 16324089 RESULT

• Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.

  PMID: 10816186 RESULT

• Nutt JG, Carter JH, Lea ES, Sexton GJ. Evolution of the response to levodopa during the first 4 years of therapy. Ann Neurol. 2002 Jun;51(6):686-93. doi: 10.1002/ana.10189.

  PMID: 12112073 RESULT

• Chung KA, Lobb BM, Nutt JG, McNames J, Horak F. Objective measurement of dyskinesia in Parkinson's disease using a force plate. Mov Disord. 2010 Apr 15;25(5):602-8. doi: 10.1002/mds.22856.

  PMID: 20213818 RESULT

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Docosahexaenoic Acids; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Carbohydrates

Results Point of Contact

• Title: Kathryn Chung, MD
• Organization: VA Portland Health Care System

Kathryn.Chung@va.gov

5037211091

Study Officials

• Kathryn Anne Chung, MD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 27, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)