Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 1

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).
    

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.
    

Intervention name(s): Docosahexaenoic Acid (DHA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years; Sugar Pill, taken for 1.5 years
Other intervention name(s): DHA; Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Parkinsons disease; supplement; DHA; dyskinesia; abnormal movements