Trial Outcomes & Findings for Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients (NCT NCT02453386)
NCT ID: NCT02453386
Last Updated: 2019-04-03
Results Overview
Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia". Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
Baseline to 24 Weeks
Results posted on
2019-04-03
Participant Flow
This study was conducted at 80 sites in 7 countries. Planned patient enrollment numbers were achieved, but the study and the tozadenant development program were terminated prior to study completion by all patients, based on an unexpected emerging safety signal as discussed in the safety sections of this report.
Participant milestones
| Measure |
Tozadenant 60 mg BID
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
|
Tozadenant 120 mg BID
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
|
Placebo BID
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
151
|
149
|
149
|
|
Overall Study
COMPLETED
|
102
|
100
|
108
|
|
Overall Study
NOT COMPLETED
|
49
|
49
|
41
|
Reasons for withdrawal
| Measure |
Tozadenant 60 mg BID
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
|
Tozadenant 120 mg BID
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
|
Placebo BID
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
22
|
30
|
15
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
9
|
|
Overall Study
Sponsor Terminated Study
|
14
|
8
|
11
|
|
Overall Study
Subject Terminated by Sponsor
|
1
|
1
|
1
|
|
Overall Study
Sponsor Terminated by Investigator
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients
Baseline characteristics by cohort
| Measure |
Tozadenant 60 mg BID
n=151 Participants
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
|
Tozadenant 120 mg BID
n=149 Participants
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
|
Placebo BID
n=149 Participants
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
78 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 7.57 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 8.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
434 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
438 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
69 participants
n=7 Participants
|
69 participants
n=5 Participants
|
207 participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
59 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Weight at Screening
|
78.74 kilograms
STANDARD_DEVIATION 15.725 • n=5 Participants
|
80.42 kilograms
STANDARD_DEVIATION 16.576 • n=7 Participants
|
79.35 kilograms
STANDARD_DEVIATION 14.436 • n=5 Participants
|
79.50 kilograms
STANDARD_DEVIATION 15.585 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Modified Intent-to-Treat (mITT) population
Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia". Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Baseline
|
6.34 hours
Standard Deviation 1.986
|
6.00 hours
Standard Deviation 1.970
|
6.25 hours
Standard Deviation 2.337
|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Week 2
|
-0.725 hours
Standard Deviation 2.0018
|
-1.100 hours
Standard Deviation 2.1188
|
-1.409 hours
Standard Deviation 2.3957
|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Week 6
|
-0.817 hours
Standard Deviation 2.0993
|
-1.112 hours
Standard Deviation 2.2903
|
-1.879 hours
Standard Deviation 2.2866
|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Week 12
|
-0.962 hours
Standard Deviation 2.2186
|
-1.460 hours
Standard Deviation 2.3689
|
-1.919 hours
Standard Deviation 2.2008
|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Week 18
|
0.860 hours
Standard Deviation 2.4246
|
-1.020 hours
Standard Deviation 2.5886
|
-1.742 hours
Standard Deviation 2.6855
|
|
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
Week 24
|
-0.958 hours
Standard Deviation 2.2725
|
-0.835 hours
Standard Deviation 2.9730
|
-1.789 hours
Standard Deviation 2.4802
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: Modified Intent-to-Treat (mITT) population
The first key secondary efficacy endpoint was the change from baseline to Week 24 in good ON which was defined as ON without dyskinesia or ON with non-troublesome dyskinesia. Awake Time in Good ON State (hr) is the average of a maximum of 3 days diary. Patients were asked to record ON time according to dyskinesia categories "without dyskinesia", "with non troublesome dyskinesia" or "with troublesome dyskinesia" . Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. For patients with missing baseline or baseline was measured post-dose, screening was used as baseline in the calculation of change from baseline.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Change in Good ON Time From Baseline to Week 24
Baseline
|
9.58 hours
Standard Deviation 2.266
|
9.92 hours
Standard Deviation 2.217
|
9.51 hours
Standard Deviation 2.554
|
|
Change in Good ON Time From Baseline to Week 24
Week 2
|
0.790 hours
Standard Deviation 2.2778
|
1.145 hours
Standard Deviation 2.1291
|
1.397 hours
Standard Deviation 2.5102
|
|
Change in Good ON Time From Baseline to Week 24
Week 6
|
0.812 hours
Standard Deviation 2.4177
|
1.002 hours
Standard Deviation 2.4533
|
1.650 hours
Standard Deviation 2.2538
|
|
Change in Good ON Time From Baseline to Week 24
Week 12
|
0.777 hours
Standard Deviation 2.4300
|
1.307 hours
Standard Deviation 2.7051
|
1.830 hours
Standard Deviation 2.2870
|
|
Change in Good ON Time From Baseline to Week 24
Week 18
|
0.709 hours
Standard Deviation 2.6284
|
0.903 hours
Standard Deviation 2.6297
|
1.553 hours
Standard Deviation 2.6138
|
|
Change in Good ON Time From Baseline to Week 24
Week 24
|
1.011 hours
Standard Deviation 2.5470
|
0.705 hours
Standard Deviation 3.1219
|
1.689 hours
Standard Deviation 2.7335
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit.
The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale to monitor Parkinson's Disease related disability and impairment. The scale itself has 4 components are titled; (1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this outcome measure we are evaluating Part II and Part III. Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Range of score is 0 - 160: 0 meaning less impact and Higher score indicates greater impact of PD symptoms.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Baseline
|
33.2 score on a scale
Standard Deviation 12.14
|
31.3 score on a scale
Standard Deviation 12.18
|
32.3 score on a scale
Standard Deviation 12.08
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Week 2
|
-3.16 score on a scale
Standard Deviation 5.931
|
-3.43 score on a scale
Standard Deviation 6.611
|
-3.96 score on a scale
Standard Deviation 5.924
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Week 6
|
-3.53 score on a scale
Standard Deviation 6.375
|
-2.82 score on a scale
Standard Deviation 7.223
|
-4.31 score on a scale
Standard Deviation 6.362
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Week 12
|
-3.02 score on a scale
Standard Deviation 8.385
|
-3.64 score on a scale
Standard Deviation 7.393
|
-4.38 score on a scale
Standard Deviation 6.602
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Week 18
|
-3.35 score on a scale
Standard Deviation 7.934
|
-3.63 score on a scale
Standard Deviation 7.958
|
-3.83 score on a scale
Standard Deviation 7.150
|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function
Week 24
|
-2.80 score on a scale
Standard Deviation 8.183
|
-2.54 score on a scale
Standard Deviation 8.584
|
-3.68 score on a scale
Standard Deviation 7.853
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit.
Change from Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts III Motor Function (motor subscale) total scores. Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Range of score is 0 - 108. Higher scores indicate greater impact of PD symptoms. Unified Parkinson's Disease Rating Scale (UPDRS) in the ON state was measured at a time representative of the ON state in that patient, not in "best" ON. Unified Parkinson's Disease Rating Scale Part III in OFF was not evaluated.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Baseline
|
20.9 score on a scale
Standard Deviation 8.80
|
19.8 score on a scale
Standard Deviation 8.58
|
20.5 score on a scale
Standard Deviation 8.71
|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Week 2
|
-2.13 score on a scale
Standard Deviation 4.828
|
-2.35 score on a scale
Standard Deviation 5.144
|
-2.83 score on a scale
Standard Deviation 4.613
|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Week 6
|
-2.29 score on a scale
Standard Deviation 5.011
|
-2.18 score on a scale
Standard Deviation 5.476
|
-2.76 score on a scale
Standard Deviation 5.423
|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Week 12
|
-2.31 score on a scale
Standard Deviation 6.276
|
-2.69 score on a scale
Standard Deviation 5.822
|
-3.19 score on a scale
Standard Deviation 5.356
|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Week 18
|
-2.46 score on a scale
Standard Deviation 6.112
|
-2.64 score on a scale
Standard Deviation 6.303
|
-2.95 score on a scale
Standard Deviation 5.572
|
|
Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl
Week 24
|
-2.15 score on a scale
Standard Deviation 6.363
|
-2.13 score on a scale
Standard Deviation 6.822
|
-2.93 score on a scale
Standard Deviation 6.048
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 24Population: mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized.
For the Clinical Global Impression of Improvement (CGI-I), the investigator or rater is asked to rate the patient's total improvement, whether or not in his or her judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale ranging from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Tables show Treatment vs Placebo.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
Week 2
|
3.5 score on a scale
Standard Deviation 0.80
|
3.4 score on a scale
Standard Deviation 0.87
|
3.2 score on a scale
Standard Deviation 0.85
|
|
Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
Week 6
|
3.4 score on a scale
Standard Deviation 0.86
|
3.3 score on a scale
Standard Deviation 0.96
|
3.2 score on a scale
Standard Deviation 0.93
|
|
Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
Week 12
|
3.5 score on a scale
Standard Deviation 0.98
|
3.3 score on a scale
Standard Deviation 1.01
|
3.2 score on a scale
Standard Deviation 0.92
|
|
Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
Week 18
|
3.5 score on a scale
Standard Deviation 1.04
|
3.5 score on a scale
Standard Deviation 0.92
|
3.2 score on a scale
Standard Deviation 0.97
|
|
Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24
Week 24
|
3.5 score on a scale
Standard Deviation 0.92
|
3.5 score on a scale
Standard Deviation 1.07
|
3.2 score on a scale
Standard Deviation 0.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 24Population: mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized.
For the Patient Global Impression of Improvement (PG-I), the patient is asked to rate the total improvement of their Parkinson's Disease, whether or not in the patient's judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale. "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed. Scale: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severly ill, 7 = Among the most extremely ill. Tables show Treatment vs Placebo.
Outcome measures
| Measure |
Placebo BID
n=145 Participants
Two placebo tablets BID
|
Tozadenant 60 mg BID
n=144 Participants
One 60 mg tozadenant tablet BID plus 1 Placebo
|
Tozadenant 120 mg BID
n=145 Participants
Two 60 mg tozadenant tablets BID
|
|---|---|---|---|
|
Patient Global Impression of Improvement (PGI-I) Week 24
Week 2
|
3.6 score on a scale
Standard Deviation 0.90
|
3.3 score on a scale
Standard Deviation 1.02
|
3.1 score on a scale
Standard Deviation 1.00
|
|
Patient Global Impression of Improvement (PGI-I) Week 24
Week 6
|
3.5 score on a scale
Standard Deviation 0.92
|
3.4 score on a scale
Standard Deviation 1.22
|
3.1 score on a scale
Standard Deviation 1.02
|
|
Patient Global Impression of Improvement (PGI-I) Week 24
Week 12
|
3.5 score on a scale
Standard Deviation 1.16
|
3.5 score on a scale
Standard Deviation 1.21
|
3.1 score on a scale
Standard Deviation 1.13
|
|
Patient Global Impression of Improvement (PGI-I) Week 24
Week 18
|
3.6 score on a scale
Standard Deviation 1.03
|
3.6 score on a scale
Standard Deviation 1.13
|
3.2 score on a scale
Standard Deviation 1.08
|
|
Patient Global Impression of Improvement (PGI-I) Week 24
Week 24
|
3.6 score on a scale
Standard Deviation 1.14
|
3.6 score on a scale
Standard Deviation 1.21
|
3.4 score on a scale
Standard Deviation 1.14
|
Adverse Events
Tozadenant 60 mg BID
Serious events: 13 serious events
Other events: 115 other events
Deaths: 1 deaths
Tozadenant 120 mg BID
Serious events: 12 serious events
Other events: 111 other events
Deaths: 1 deaths
Placebo BID
Serious events: 15 serious events
Other events: 111 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tozadenant 60 mg BID
n=150 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
|
Tozadenant 120 mg BID
n=149 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
|
Placebo BID
n=148 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
General disorders
Asthenia
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
General disorders
Gait disturbance
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Appendicitis
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Bronchitis
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Septic shock
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.4%
2/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Dyskinesia
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Parkinson's disease
|
1.3%
2/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Vascular disorders
Hypertension
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
Other adverse events
| Measure |
Tozadenant 60 mg BID
n=150 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets, one 60 mg tozadenant and one placebo, by mouth BID for a total of four (4) tablets per day.
|
Tozadenant 120 mg BID
n=149 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets of 60 mg tozadenant, by mouth BID for a total of four (4) tablets per day.
|
Placebo BID
n=148 participants at risk
Part A (double-blind phase)
During Part A, patients took two (2) tablets of placebo, by mouth BID for a total of four (4) tablets per day.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
15/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
5.4%
8/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.4%
2/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.3%
2/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
8/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
8.7%
13/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.1%
6/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
General disorders
Fatigue
|
4.7%
7/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.4%
2/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
7/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
3.4%
5/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.8%
10/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Urinary Tract Infection
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.0%
9/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
3.4%
5/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Injury, poisoning and procedural complications
Fall
|
14.7%
22/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
8.7%
13/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.1%
9/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.0%
6/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Investigations
Weight decreased
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.7%
7/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
5.4%
8/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
5/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.1%
6/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Dizziness
|
4.7%
7/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.7%
7/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.1%
9/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Somnolence
|
3.3%
5/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
5.4%
8/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
3.4%
5/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Sudden onset of sleep
|
4.7%
7/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.7%
7/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Anxiety
|
3.3%
5/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Hallucination, visual
|
5.3%
8/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
5.4%
8/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.4%
2/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Insomnia
|
6.0%
9/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.0%
9/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
6.1%
9/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Renal and urinary disorders
Micturition urgency
|
2.0%
3/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.4%
2/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Vascular disorders
Flushing
|
0.67%
1/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Dyskinesia
|
14.7%
22/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
14.8%
22/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
8.8%
13/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Confusional state
|
1.3%
2/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Parkinson's disease
|
7.3%
11/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.7%
7/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
6/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.67%
1/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.7%
7/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Vascular disorders
Hypertension
|
3.3%
5/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.0%
3/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
4.1%
6/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Investigations
White Blood cell count decreased
|
1.3%
2/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
2.7%
4/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Nervous system disorders
Headache
|
2.0%
3/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
1.3%
2/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
3.4%
5/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.68%
1/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
|
Psychiatric disorders
Disorientation
|
2.7%
4/150 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/149 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
0.00%
0/148 • 24 Weeks
The Adverse Events was based on the Safety Set Population (SS). The SS included 447 of the 449 (ITT Population) randomized patients as two patients who were randomized were not dosed.
|
Additional Information
Christopher Kenney, Senior Vice President - Medical Affairs
Acorda Therapeutics
Phone: 914-326-5775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER