Trial Outcomes & Findings for Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) (NCT NCT00644423)
NCT ID: NCT00644423
Last Updated: 2019-08-20
Results Overview
Mean change scores in posttraumatic stress disorder symptoms (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Results posted on
2019-08-20
Participant Flow
18 participants enrolled; 11 participants started (randomized at Week 2) after a 2-week placebo lead in
Participant milestones
| Measure |
Omega-3 Fatty Acid
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Omega-3 Fatty Acid
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
Placebo: Matching Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Omega-3 Fatty Acid
n=6 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 Participants
Placebo: Matching Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 10.67 • n=99 Participants
|
43.6 years
STANDARD_DEVIATION 18.83 • n=107 Participants
|
40.9 years
STANDARD_DEVIATION 14.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores in posttraumatic stress disorder symptoms (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=6 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
-6.50 units on a scale
Standard Error 5.124
|
-18.60 units on a scale
Standard Error 7.961
|
PRIMARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores to assess cognitive changes (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=6 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Brief Assessment of Cognition in Affective Disorders (BAC-A)
|
0.2583 Z-score
Standard Error 0.2078
|
0.2860 Z-score
Standard Error 0.1652
|
SECONDARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores in depressive symptomatology (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability, sleep,weight/appetite change, and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity). Higher values reflect more severe symptoms.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=6 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology (QIDS)
|
1.167 units on a scale
Standard Error 2.056
|
-1.000 units on a scale
Standard Error 1.000
|
SECONDARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores in resiliency (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=6 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=4 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Connor Davidson Resilience Scale (CD-RISC)
|
-2.000 units on a scale
Standard Error 3.759
|
1.000 units on a scale
Standard Error 5.986
|
SECONDARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Population: Missing CPT scores from 2 participants in the Omega-3 Fatty Acid arm.
Mean change scores in inpulsivity (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=4 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Continuous Performance Test (CPT)
|
0.6920 Q-score
Standard Error 0.3369
|
0.6198 Q-score
Standard Error 0.2911
|
SECONDARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores in cognition and attention (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a line from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=5 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=4 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Trail Making A
|
-3.140 seconds
Standard Error 2.112
|
-11.14 seconds
Standard Error 1.570
|
SECONDARY outcome
Timeframe: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)Mean change scores in attention and cognition (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part B is a timed test that consists of 25 circles on a piece of paper with both numbers (1 - 13) and letters (A - L); the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The respondent is asked to draw a line from number one, and so on,in correct numerical/alphabetical order, until they reach number 13. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Outcome measures
| Measure |
Omega-3 Fatty Acid
n=5 Participants
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=4 Participants
Placebo: Matching Placebo
|
|---|---|---|
|
Trail Making B
|
-20.84 seconds
Standard Error 11.77
|
-30.65 seconds
Standard Error 24.17
|
Adverse Events
Omega-3 Fatty Acid
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega-3 Fatty Acid
n=6 participants at risk
Omega-3 Fatty Acid: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)
|
Placebo
n=5 participants at risk
Placebo: Matching Placebo
|
|---|---|---|
|
General disorders
Sweating
|
33.3%
2/6 • Number of events 4 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Drowsiness
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Dry Mouth
|
50.0%
3/6 • Number of events 4 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Excitement/Agitation
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Cramps
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 4 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Restlessness
|
50.0%
3/6 • Number of events 5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Increased Appetite
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Decreased Interest in Sex
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Decreased Appetite
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Disorientation
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Headache
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
40.0%
2/5 • Number of events 3 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Nausea
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Increased Motor Activity
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Reproductive system and breast disorders
Menstrual Disturbance
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Stiffness
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Insomnia
|
16.7%
1/6 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 2 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Akathisia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Decreased Motor Activity
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Hypersomnia
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Impaired Sex Performance
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint Pain/Stiffness
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
0.00%
0/5 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Nasal Congestion
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Tremor
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
|
General disorders
Vertigo
|
0.00%
0/6 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place