Trial Outcomes & Findings for Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures (NCT NCT00871377)
NCT ID: NCT00871377
Last Updated: 2014-02-07
Results Overview
Seizure frequency (seizures per day or seizures per month)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Study completion (42 weeks)
Results posted on
2014-02-07
Participant Flow
Subjects were recruited from the local epilepsy society, and from flyers posted in the epilepsy clinic at UCLA, and from referrals within the UCLA Department of Neurology
Participant milestones
| Measure |
P L H
Placebo, then Low Dose, then High Dose
|
P H L
Placebo, then High Dose, then Low Dose
|
L H P
Low Dose, then High Dose, then Placebo
|
L P H
Low Dose, then Placebo, then High Dose
|
H L P
High Dose, then Low Dose, then Placebo
|
H P L
High Dose, then Placebo, then Low Dose
|
|---|---|---|---|---|---|---|
|
First Intervention (10 Weeks)
STARTED
|
3
|
4
|
4
|
4
|
4
|
5
|
|
First Intervention (10 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
First Intervention (10 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Washout (6 Weeks)
STARTED
|
2
|
4
|
3
|
4
|
4
|
4
|
|
Washout (6 Weeks)
COMPLETED
|
2
|
4
|
3
|
4
|
4
|
3
|
|
Washout (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Intervention (10 Weeks)
STARTED
|
2
|
4
|
3
|
4
|
4
|
4
|
|
Second Intervention (10 Weeks)
COMPLETED
|
2
|
4
|
3
|
4
|
4
|
4
|
|
Second Intervention (10 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (10 Weeks)
STARTED
|
2
|
4
|
3
|
4
|
4
|
3
|
|
Third Intervention (10 Weeks)
COMPLETED
|
2
|
4
|
3
|
3
|
4
|
3
|
|
Third Intervention (10 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
P L H
Placebo, then Low Dose, then High Dose
|
P H L
Placebo, then High Dose, then Low Dose
|
L H P
Low Dose, then High Dose, then Placebo
|
L P H
Low Dose, then Placebo, then High Dose
|
H L P
High Dose, then Low Dose, then Placebo
|
H P L
High Dose, then Placebo, then Low Dose
|
|---|---|---|---|---|---|---|
|
First Intervention (10 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention (10 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout (6 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Intervention (10 Weeks)
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
Baseline characteristics by cohort
| Measure |
Baseline
n=24 Participants
The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
|
|---|---|
|
Age, Continuous
|
33.04 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study completion (42 weeks)Seizure frequency (seizures per day or seizures per month)
Outcome measures
| Measure |
Placebo
n=22 Participants
Corn Oil - 6 capsules per day
|
Fish Oil Low Dose
n=20 Participants
Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
|
Fish OIl High Dose
n=20 Participants
Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
|
|---|---|---|---|
|
Seizure Frequency
|
0.655 Seizures per Day
Standard Error 0.153
|
0.435 Seizures per Day
Standard Error 0.097
|
0.631 Seizures per Day
Standard Error 0.163
|
Adverse Events
High Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose
n=20 participants at risk
High Dose Fish Oil Intervention
|
Low Dose
n=20 participants at risk
Low Dose Fish Oil Intervention
|
Placebo
n=22 participants at risk
Corn Oil Placebo
|
|---|---|---|---|
|
Cardiac disorders
Sudden Death in Epilepsy
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/22
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place