Trial Outcomes & Findings for Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome (NCT NCT01332305)
NCT ID: NCT01332305
Last Updated: 2013-07-22
Results Overview
Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
217 participants
Primary outcome timeframe
Weeks 4 and 12
Results posted on
2013-07-22
Participant Flow
Participant milestones
| Measure |
GEn Placebo
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
48
|
45
|
38
|
45
|
|
Overall Study
COMPLETED
|
31
|
34
|
31
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
14
|
8
|
12
|
Reasons for withdrawal
| Measure |
GEn Placebo
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
6
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
4
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Sponsor
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Treatment Failure
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
GEn Placebo
n=41 Participants
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=48 Participants
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=45 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=38 Participants
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=45 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
47.1 Years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
47.3 Years
STANDARD_DEVIATION 12.78 • n=7 Participants
|
49.8 Years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
50.2 Years
STANDARD_DEVIATION 13.79 • n=4 Participants
|
45.9 Years
STANDARD_DEVIATION 13.93 • n=21 Participants
|
48.0 Years
STANDARD_DEVIATION 12.67 • n=8 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
139 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
78 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
39 participants
n=5 Participants
|
48 participants
n=7 Participants
|
44 participants
n=5 Participants
|
35 participants
n=4 Participants
|
42 participants
n=21 Participants
|
208 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Weeks 4 and 12Population: Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).
Css, max is defined as the maximum or "peak" concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.
Outcome measures
| Measure |
GEn Placebo
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=39 Participants
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=33 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=33 Participants
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=36 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Mean Css, Max and Css, Min
Css, min; Week 4, n=0, 39, 33, 33, 36
|
—
|
0.690 nanograms per milliliter (ng/ml)
Standard Deviation 0.359
|
1.37 nanograms per milliliter (ng/ml)
Standard Deviation 0.894
|
1.63 nanograms per milliliter (ng/ml)
Standard Deviation 0.967
|
2.34 nanograms per milliliter (ng/ml)
Standard Deviation 1.78
|
|
Mean Css, Max and Css, Min
Css, max; Week 4, n=0, 39, 33, 33, 36
|
—
|
3.86 nanograms per milliliter (ng/ml)
Standard Deviation 1.25
|
7.14 nanograms per milliliter (ng/ml)
Standard Deviation 2.62
|
11.4 nanograms per milliliter (ng/ml)
Standard Deviation 3.54
|
14.0 nanograms per milliliter (ng/ml)
Standard Deviation 4.23
|
|
Mean Css, Max and Css, Min
Css, max; Week 12, n=0, 32, 30, 30, 31
|
—
|
4.14 nanograms per milliliter (ng/ml)
Standard Deviation 1.19
|
7.15 nanograms per milliliter (ng/ml)
Standard Deviation 2.76
|
12.0 nanograms per milliliter (ng/ml)
Standard Deviation 3.83
|
13.3 nanograms per milliliter (ng/ml)
Standard Deviation 3.83
|
|
Mean Css, Max and Css, Min
Css, min; Week 12, n=0, 32, 30, 30, 31
|
—
|
0.600 nanograms per milliliter (ng/ml)
Standard Deviation 0.332
|
1.32 nanograms per milliliter (ng/ml)
Standard Deviation 1.15
|
1.60 nanograms per milliliter (ng/ml)
Standard Deviation 0.994
|
2.41 nanograms per milliliter (ng/ml)
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Weeks 4 and 12Population: Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).
Tmax is defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.
Outcome measures
| Measure |
GEn Placebo
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=39 Participants
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=33 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=33 Participants
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=36 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Mean Tmax and T1/2
Tmax; Week 4, n=0, 39, 33, 33, 36
|
—
|
8.76 hours
Standard Deviation 3.81
|
8.57 hours
Standard Deviation 3.16
|
7.61 hours
Standard Deviation 2.67
|
8.01 hours
Standard Deviation 3.62
|
|
Mean Tmax and T1/2
Tmax; Week 12, n=0, 32, 30, 30, 31
|
—
|
6.96 hours
Standard Deviation 3.76
|
8.72 hours
Standard Deviation 3.68
|
8.00 hours
Standard Deviation 2.58
|
8.13 hours
Standard Deviation 3.20
|
|
Mean Tmax and T1/2
T1/2; Week 4, n=0, 38, 33, 33, 35
|
—
|
5.82 hours
Standard Deviation 1.46
|
6.67 hours
Standard Deviation 1.94
|
5.82 hours
Standard Deviation 1.56
|
6.05 hours
Standard Deviation 1.11
|
|
Mean Tmax and T1/2
T1/2, Week 12, n=0, 32, 30, 30, 30
|
—
|
6.27 hours
Standard Deviation 1.77
|
6.63 hours
Standard Deviation 2.23
|
5.89 hours
Standard Deviation 1.36
|
6.09 hours
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Weeks 4 and 12Population: Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.
Outcome measures
| Measure |
GEn Placebo
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=38 Participants
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=33 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=33 Participants
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=35 Participants
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Mean AUCss
Week 4, n=0, 38, 33, 33, 35
|
—
|
49.3 ng*hour/ml
Standard Deviation 14.8
|
96.1 ng*hour/ml
Standard Deviation 30.4
|
141 ng*hour/ml
Standard Deviation 41.0
|
176 ng*hour/ml
Standard Deviation 53.8
|
|
Mean AUCss
Week 12, n=0, 32, 30, 30, 30
|
—
|
51.4 ng*hour/ml
Standard Deviation 16.5
|
95.7 ng*hour/ml
Standard Deviation 38.5
|
146 ng*hour/ml
Standard Deviation 41.4
|
173 ng*hour/ml
Standard Deviation 54.4
|
Adverse Events
GEn Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
GEn 600 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
GEn 1200 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
GEn 1800 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
GEn 2400 mg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GEn Placebo
n=41 participants at risk
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=48 participants at risk
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=45 participants at risk
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=38 participants at risk
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=45 participants at risk
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Vascular disorders
Peripheral vascular disorder
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
Other adverse events
| Measure |
GEn Placebo
n=41 participants at risk
Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 600 mg
n=48 participants at risk
Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1200 mg
n=45 participants at risk
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
|
GEn 1800 mg
n=38 participants at risk
Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
|
GEn 2400 mg
n=45 participants at risk
Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
8.3%
4/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Nervous system disorders
Somnolence
|
4.9%
2/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
14.6%
7/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
24.4%
11/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
26.3%
10/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
51.1%
23/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
20.8%
10/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
22.2%
10/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
26.3%
10/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
40.0%
18/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Nervous system disorders
Headache
|
17.1%
7/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.2%
2/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
20.0%
9/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
10.5%
4/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
13.3%
6/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Gastrointestinal disorders
Nausea
|
12.2%
5/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.2%
3/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
8.9%
4/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
7.9%
3/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Fatigue
|
9.8%
4/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.2%
2/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
8.9%
4/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.6%
1/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
4/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
3/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
7.9%
3/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Irritability
|
4.9%
2/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.2%
2/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
10.4%
5/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.6%
1/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Feeling drunk
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
7.9%
3/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
8.9%
4/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Peripheral edema
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.6%
1/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.2%
2/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Nervous system disorders
Sedation
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
7.9%
3/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Feeling abnormal
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
7.9%
3/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
8.9%
4/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Psychiatric disorders
Disorientation
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.2%
1/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
6.7%
3/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.6%
1/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
4.4%
2/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/41 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
2.1%
1/48 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
5.3%
2/38 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
0.00%
0/45 • Treatment-Emergent Adverse Events (TEAEs) were collected from the first dose of randomized study medication through end of taper phase (up to Week 13). Any Serious Adverse Event (SAE) reported up to 30 days after last dose was also reported.
At the end of the follow-up period (30 days after the last day of taper \[Day 119\]), the study coordinator called participants (+/- 3 day window) who did not enroll in the open-label extension protocol to determine if any SAEs occurred, and the resolution date for any AEs that were ongoing at the end of the study.
|
Additional Information
XenoPort Call Center
XenoPort, Inc.
Phone: 877-936-6778
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER