Trial Outcomes & Findings for Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI) (NCT NCT01956279)
NCT ID: NCT01956279
Last Updated: 2020-05-01
Results Overview
These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Baseline to week 4, and Baseline to week 8
Results posted on
2020-05-01
Participant Flow
170 participants enrolled; 142 participants were randomized after a 2-week placebo lead-in phase. The remaining 28 randomized participants were withdrawn prior to week 4 post-randomization for various reasons - including medication changes during the study (exclusionary) and participants unavailable for continued contact.
Participant milestones
| Measure |
Pregnenolone (Arm 1)
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
88
|
|
Overall Study
COMPLETED
|
68
|
74
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
Baseline characteristics by cohort
| Measure |
Pregnenolone (Arm 1)
n=82 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=88 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
163 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
|
2 Participants
n=7 Participants
|
2 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
|
40 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
72 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
|
82 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 4, and Baseline to week 8Population: Change in the Physical Component Score of the SF-36. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.
These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.
Outcome measures
| Measure |
Pregnenolone (Arm 1)
n=66 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=74 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Physical Component of the SF-36
Baseline to week 4
|
2.04 score on a scale
Standard Error 1.50
|
2.55 score on a scale
Standard Error 1.55
|
|
Physical Component of the SF-36
Baseline to week 8
|
1.23 score on a scale
Standard Error 1.68
|
4.45 score on a scale
Standard Error 1.75
|
SECONDARY outcome
Timeframe: Baseline to week 4, and Baseline to week 8Population: Change in the average pain rating over the last 24 hours, and the magnitude of interference resulting from that pain. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.
These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline.
Outcome measures
| Measure |
Pregnenolone (Arm 1)
n=68 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=74 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Brief Pain Inventory (BPI)
Pain rating, Baseline to week 4
|
-0.44 score on a scale
Standard Error 0.14
|
-0.30 score on a scale
Standard Error 0.15
|
|
Brief Pain Inventory (BPI)
Pain rating, Baseline to week 8
|
-0.09 score on a scale
Standard Error 0.21
|
-0.11 score on a scale
Standard Error 0.22
|
|
Brief Pain Inventory (BPI)
Interference, Baseline to week 4
|
-0.03 score on a scale
Standard Error 0.22
|
0.00 score on a scale
Standard Error 0.21
|
|
Brief Pain Inventory (BPI)
Interference, Baseline to week 8
|
-0.19 score on a scale
Standard Error 0.25
|
-0.26 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline to week 4, and Baseline to week 8Population: Change in the Tower of London Score of the BAC-A. Some subjects did not reach week 8 of the study.
These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline.
Outcome measures
| Measure |
Pregnenolone (Arm 1)
n=68 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=74 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A)
Baseline to week 4
|
1.15 score on a scale
Standard Error 0.37
|
1.31 score on a scale
Standard Error 0.39
|
|
Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A)
Baseline to week 8
|
0.98 score on a scale
Standard Error 0.37
|
1.71 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline to week 4, and Baseline to week 8Population: Total score of the MFI-20. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.
These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline.
Outcome measures
| Measure |
Pregnenolone (Arm 1)
n=68 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=74 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Multidimensional Fatigue Inventory (MFI)
Baseline to week 4
|
-0.76 score on a scale
Standard Error 1.24
|
-0.27 score on a scale
Standard Error 1.04
|
|
Multidimensional Fatigue Inventory (MFI)
Baseline to week 8
|
-3.63 score on a scale
Standard Error 1.45
|
-3.22 score on a scale
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline to week 4, and Baseline to week 8Population: Average Global Severity Index score of the SCL-90. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits.
These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline.
Outcome measures
| Measure |
Pregnenolone (Arm 1)
n=68 Participants
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=74 Participants
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R)
Baseline to week 4
|
-0.12 score on a scale
Standard Error 0.04
|
-0.09 score on a scale
Standard Error 0.04
|
|
Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R)
Baseline to week 8
|
-0.16 score on a scale
Standard Error 0.05
|
-0.15 score on a scale
Standard Error 0.05
|
Adverse Events
Pregnenolone (Arm 1)
Serious events: 1 serious events
Other events: 69 other events
Deaths: 1 deaths
Placebo (Arm 2)
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregnenolone (Arm 1)
n=82 participants at risk
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=88 participants at risk
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
General disorders
Participant death by homicide
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
Other adverse events
| Measure |
Pregnenolone (Arm 1)
n=82 participants at risk
Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
|
Placebo (Arm 2)
n=88 participants at risk
Placebo: Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
|
|---|---|---|
|
General disorders
Occurrence of Blank Stare
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
8.5%
7/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Rigidity
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
4.5%
4/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Fever
|
4.9%
4/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
5.7%
5/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Irritability
|
9.8%
8/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
15.9%
14/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Blood and lymphatic system disorders
Cold Extremities
|
4.9%
4/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
13.6%
12/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Cardiac disorders
Palpitations
|
6.1%
5/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
9.1%
8/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Cardiac disorders
Tachycardia
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Ear and labyrinth disorders
Tinnitus
|
13.4%
11/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
17.0%
15/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Eye disorders
Blurred Vision
|
12.2%
10/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
21.6%
19/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Diarrhea
|
29.3%
24/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
29.5%
26/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Constipation
|
14.6%
12/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
19.3%
17/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Nausea
|
18.3%
15/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
22.7%
20/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
5/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
6.8%
6/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Restlessness
|
14.6%
12/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
15.9%
14/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Nasal Congestion
|
24.4%
20/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
37.5%
33/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Peripheral Edema
|
8.5%
7/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
9.1%
8/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
General disorders
Malaise
|
7.3%
6/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
2.3%
2/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
22.0%
18/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
23.9%
21/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Joint Pain/Stiffness
|
11.0%
9/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
6.8%
6/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain/Stiffness
|
11.0%
9/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
12.5%
11/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Akathisia
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
5.7%
5/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Increased Motor Activity
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Leg Shaking
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Drowsiness
|
19.5%
16/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
23.9%
21/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Hypersomnia
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Insomnia
|
19.5%
16/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
15.9%
14/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Decreased Appetite
|
11.0%
9/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
15.9%
14/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Increased Appetite
|
9.8%
8/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
13.6%
12/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Dry Mouth
|
18.3%
15/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
25.0%
22/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Headache
|
34.1%
28/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
28.4%
25/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Migraine Headache
|
0.00%
0/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Tremor
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
2.3%
2/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Increased Salivation
|
6.1%
5/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
5.7%
5/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Dizziness
|
20.7%
17/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
19.3%
17/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Sweating
|
15.9%
13/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
14.8%
13/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Decreased Interest in Sex
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
8.0%
7/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Impaired Sexual Performance
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
10.2%
9/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Vertigo
|
6.1%
5/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
4.5%
4/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Excitement / Agitation
|
7.3%
6/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
4.5%
4/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Confusion
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
3.4%
3/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Paresthesia
|
18.3%
15/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
11.4%
10/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Renal and urinary disorders
Nocturnal/Enuresis
|
0.00%
0/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Renal and urinary disorders
Urinary Retention
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
2.3%
2/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Reproductive system and breast disorders
Menstrual Disturbance
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
4.5%
4/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
20.7%
17/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
21.6%
19/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Change in Stool Color
|
0.00%
0/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Decreased Motor Activity
|
3.7%
3/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
2.3%
2/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Musculoskeletal and connective tissue disorders
Pain / Stiffness
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
8.0%
7/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Disorientation
|
4.9%
4/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
3.4%
3/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Nervous system disorders
Forgetfulness
|
0.00%
0/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
1.1%
1/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
|
Cardiac disorders
Hypertension
|
2.4%
2/82 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
0.00%
0/88 • Participants were followed for 10 weeks (or somewhat less if the participant was lost to follow-up or withdrawn during the study), with all subjects completed in a 4.5 year span.
Adverse events were assessed with a structured rating scale (Hillside) every two weeks at each study visit. In addition, this structured adverse event rating scale was administered during telephone check-in assessments in between each study visit (i.e. administered weekly, either in person or by phone).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place