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Parkinson's DiseasePhase 1RLID-PDNCT01563913

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

A Phase 1 study testing Docosahexaenoic Acid (DHA) in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Docosahexaenoic Acid (DHA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
Oct 2012to Jun 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Docosahexaenoic Acid (DHA), Placebo
Keywords
Parkinsons disease, supplement, DHA, dyskinesia, abnormal movements
Medical subject headings
Parkinson Disease, Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic Acid (DHA)Drug

    Also called DHA

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

  • PlaceboDrug

    Also called Sugar Pill

    Sugar Pill, taken for 1.5 years

Study groups in NCT01563913
Study groupRoleWhat they receive
Arm 1ExperimentalDocosahexaenoic Acid (DHA)
Receives: Drug: Docosahexaenoic Acid (DHA)
Arm 2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of DHA - Change in Blood ng/dL Levels

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

    Measured: baseline and 1.5 years

  2. 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.

    Measured: Year 1

Secondary outcomes (1)

  1. Forceplate Measured Dyskinesia

    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.

    Measured: baseline and 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563913
Sponsor's protocol ID
CLIN-006-11S
Other IDs
2907, 8012
Acronym
RLID-PD
Status last verified
May 2018
First submitted
16 Mar 2012
Last updated
29 Jun 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 11724467

  • 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.

    PubMed 16324089

  • 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.

    PubMed 10816186

  • 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.

    PubMed 12112073

  • 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.

    PubMed 20213818

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docosahexaenoic Acid (DHA) in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of DHA - Change in Blood ng/dL Levels (time frame: baseline and 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563913, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.

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