Trial Outcomes & Findings for Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis (NCT NCT00165776)
NCT ID: NCT00165776
Last Updated: 2014-03-10
Results Overview
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2014-03-10
Participant Flow
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
Participant milestones
| Measure |
Placebo
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
33
|
31
|
|
Overall Study
COMPLETED
|
31
|
33
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
2
|
0
|
|
Overall Study
Worsening of Cervical Dystonia
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Less than 40 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Customized
40 to less than 60 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Customized
Greater than or equal to 60 years
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Full Analysis Set (FAS) population: All subjects who received study treatment
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment
|
3 Points on a Scale
Standard Error 1.3
|
8.9 Points on a Scale
Standard Error 1.8
|
7.6 Points on a Scale
Standard Error 1.6
|
10.5 Points on a Scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: "Considering all the ways your cervical dystonia affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment
|
-0.4 Millimeters
Standard Error 3.2
|
11.9 Millimeters
Standard Error 2.6
|
9.9 Millimeters
Standard Error 3
|
13.3 Millimeters
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment
|
2 Millimeters
Standard Error 2.2
|
10.6 Millimeters
Standard Error 2.9
|
11.2 Millimeters
Standard Error 2.6
|
16.9 Millimeters
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment
|
0.6 Points on a Scale
Standard Error 0.7
|
2.5 Points on a Scale
Standard Error 0.6
|
1.9 Points on a Scale
Standard Error 0.8
|
3.1 Points on a Scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment
|
0.8 Points on a Scale
Standard Error 0.4
|
2.9 Points on a Scale
Standard Error 0.7
|
2 Points on a Scale
Standard Error 0.7
|
2.7 Points on a Scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment
|
1.6 Points on a Scale
Standard Error 0.6
|
3.5 Points on a Scale
Standard Error 0.8
|
3.7 Points on a Scale
Standard Error 0.7
|
4.7 Points on a Scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: FAS
Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.
Outcome measures
| Measure |
Placebo
n=33 Participants
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 Participants
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 Participants
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 Participants
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment
|
-6.6 Millimeters
Standard Error 4.1
|
-15 Millimeters
Standard Error 4.5
|
-13.4 Millimeters
Standard Error 4.7
|
-8.7 Millimeters
Standard Error 4.4
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
E2014 2,500 U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
E2014 5,000 U
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
E2014 10,000 U
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 participants at risk
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 participants at risk
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 participants at risk
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.2%
1/31 • Number of events 1 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.2%
1/31 • Number of events 1 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 2,500 U
n=34 participants at risk
2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 5,000 U
n=32 participants at risk
5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
E2014 10,000 U
n=31 participants at risk
10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
2.9%
1/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
9.4%
3/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
22.6%
7/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
General disorders
Thirst
|
3.0%
1/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
2.9%
1/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.1%
1/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
19.4%
6/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Infections and infestations
Nasopharyngitis
|
27.3%
9/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
5.9%
2/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
12.5%
4/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
19.4%
6/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
2.9%
1/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.1%
1/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
9.7%
3/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
General disorders
Injection Site Pain
|
6.1%
2/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
6.2%
2/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.2%
1/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
3.0%
1/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
5.9%
2/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
6.5%
2/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
0.00%
0/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
12.9%
4/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
|
Investigations
Glucose Urine Present
|
0.00%
0/33 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
2.9%
1/34 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
3.1%
1/32 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
6.5%
2/31 • Baseline to last observation carried forward
130 patients (33 of the placebo group, 34 of the 2500U group, 32 of the 5000U group, and 31 of the 10000U group) received study treatment, but after randomization, 3 patients (2 of the placebo group and 1 of the 5000U group) had no treatment. The reason was that 2 of them requested withdrawal from the study and 1 ceased to return for visits.
|
Additional Information
Hiroki Shimizu, Study Director
Eisai Co., Ltd.
Phone: +81-3-3817-5245
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place