Trial Outcomes & Findings for Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids (NCT NCT01563913)

NCT ID: NCT01563913

Last Updated: 2018-06-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 33 participants
• Primary outcome timeframe: baseline and 1.5 years
• Results posted on: 2018-06-29

Participant Flow

Subjects were recruited from two large urban hospitals with Movement disorder specialty clinics in the NW USA over a 30 month (2.5 year) recruitment period. 34 subjects were screened. 1 subject screen failed due to prior exposure to levodopa. 33 subjects were randomized to DHA or placebo arms. 30 subjects returned and completed visit 1.

Participant milestones

Measure	Docosahexaenoic Acid (DHA) Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo Placebo: Sugar Pill, taken for 1.5 years
Overall Study STARTED	15	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Docosahexaenoic Acid (DHA) Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo Placebo: Sugar Pill, taken for 1.5 years
Overall Study Physician Decision	1	0
Overall Study Spouse Passed Away	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Docosahexaenoic Acid n=15 Participants Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=15 Participants Placebo: Sugar Pill, taken for 1.5 years	Total n=30 Participants Total of all reporting groups
Age, Continuous	68.3 years STANDARD_DEVIATION 7.6 • n=5 Participants	67.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	68.0 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
PD Symptom Duration	3.2 years STANDARD_DEVIATION 1.9 • n=5 Participants	4.6 years STANDARD_DEVIATION 3.8 • n=7 Participants	3.8 years STANDARD_DEVIATION 2.9 • n=5 Participants
Education	16.0 years STANDARD_DEVIATION 3.2 • n=5 Participants	15.7 years STANDARD_DEVIATION 3.1 • n=7 Participants	15.9 years STANDARD_DEVIATION 3.2 • n=5 Participants
DHA Intake at Screening	119.9 mg/day STANDARD_DEVIATION 77.4 • n=5 Participants	148.7 mg/day STANDARD_DEVIATION 88.1 • n=7 Participants	134.8 mg/day STANDARD_DEVIATION 82.9 • n=5 Participants
MoCA Score	25.1 units on a scale STANDARD_DEVIATION 3.8 • n=5 Participants	24.7 units on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	24.9 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
Unified Parkinsons Disease Rating Scale (UPDRS-III)	34.6 units on a scale STANDARD_DEVIATION 9.7 • n=5 Participants	29.2 units on a scale STANDARD_DEVIATION 10.9 • n=7 Participants	31.9 units on a scale STANDARD_DEVIATION 10.5 • n=5 Participants
Hoehn & Yahr	2.5 units on a scale n=5 Participants	2.0 units on a scale n=7 Participants	2.25 units on a scale n=5 Participants
Levodopa Initial Dose	300.0 mg/day n=5 Participants	300.0 mg/day n=7 Participants	300.0 mg/day n=5 Participants
Levodopa Exposure (Equivalence)	540.0 mg/day n=5 Participants	187.5 mg/day n=7 Participants	345.0 mg/day n=5 Participants

PRIMARY outcome

Timeframe: baseline and 1.5 years

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

Outcome measures

Measure	Docosahexaenoic Acid n=13 Participants Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=15 Participants Placebo: Sugar Pill, taken for 1.5 years
Efficacy of DHA - Change in Blood ng/dL Levels	102.18 ng/dL - Blood Standard Deviation 50.0	-13.20 ng/dL - Blood Standard Deviation 33.12

PRIMARY outcome

Timeframe: Year 1

Population: 3 participants did not complete year 1 visit (2 withdrew prior to year 1, 1 refused to travel for visit), 2 blood samples were hemolyzed and could not be analyzed.

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.

Outcome measures

Measure	Docosahexaenoic Acid n=11 Participants Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=14 Participants Placebo: Sugar Pill, taken for 1.5 years
Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline and 1.5 years

Population: Docosahexaenoic Acid Arm: 2 participants withdrew after the 6 week visit, 4 didn't complete visit 5 due to: wife's death, too busy, new diagnosis of cancer.

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.

Outcome measures

Measure	Docosahexaenoic Acid n=9 Participants Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=15 Participants Placebo: Sugar Pill, taken for 1.5 years
Forceplate Measured Dyskinesia Dyskinesia Present	3 Participants	6 Participants
Forceplate Measured Dyskinesia Dyskinesia Absent	6 Participants	9 Participants

Adverse Events

Docosahexaenoic Acid

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo:

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Docosahexaenoic Acid n=15 participants at risk Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=15 participants at risk Placebo: Sugar Pill, taken for 1.5 years
Reproductive system and breast disorders Prostate Cancer	0.00% 0/15 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	6.7% 1/15 • Number of events 1 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Nervous system disorders Syncope	0.00% 0/15 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	6.7% 1/15 • Number of events 1 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.

Other adverse events

Measure	Docosahexaenoic Acid n=15 participants at risk Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years	Placebo: n=15 participants at risk Placebo: Sugar Pill, taken for 1.5 years
Cardiac disorders Atrial Fibrillation	6.7% 1/15 • Number of events 1 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	13.3% 2/15 • Number of events 2 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Gastrointestinal disorders Nausea	33.3% 5/15 • Number of events 5 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	13.3% 2/15 • Number of events 2 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Infections and infestations Urinary Track Infection	0.00% 0/15 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	13.3% 2/15 • Number of events 3 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 2 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	0.00% 0/15 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Reproductive system and breast disorders Gynecomastia	13.3% 2/15 • Number of events 2 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	0.00% 0/15 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.	13.3% 2/15 • Number of events 2 • Adverse Event data were collected over 1.5 years. Regular monthly phone calls were placed to participants to ask about adverse events, hospitalizations, and changes in medications. Adverse events were also gathered at the in-person visit occurring at 0 weeks, 6 weeks, 24 weeks, 52 weeks, and 72 weeks.

Additional Information

Kathryn Chung, MD

VA Portland Health Care System

Phone: 5037211091

Email: Kathryn.Chung@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place