Phase 1
N=30
Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01563913 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
May 2018
Primary outcome: Primary: Efficacy of DHA - Change in Blood ng/dL Levels — 102.18; -13.20 ng/dL - Blood
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Docosahexaenoic Acid (DHA) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of DHA - Change in Blood ng/dL Levels |
102.18; -13.20 | — |
| PRIMARY Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC) |
0; 0 | — |
| SECONDARY Forceplate Measured Dyskinesia |
3; 6; 6; 9 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01563913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.