Trial Outcomes & Findings for Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (NCT NCT00647296)
NCT ID: NCT00647296
Last Updated: 2021-07-08
Results Overview
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-07-08
Participant Flow
Subjects were recruited for the study across 20 recruiting centers US between 09 April 2008 and 26 January 2009 in medical centers located the USA.
Study conducted in 2 parts: When the first 12 weeks (Part 1) was completed, eligible continuing subjects entered a 4 week placebo washout before being re-randomized to receive either 50 mg/day dexpramipexole or 300 mg/day dexpramipexole for up to 72 additional weeks.
Participant milestones
| Measure |
Placebo Twice Daily
Placebo (PBO) BID (twice daily)
|
50 mg/Day Dexpramipexole
dexpramipexole 25 mg BID (twice daily)
|
150 mg/Day Dexpramipexole
dexpramipexole 75 mg BID (twice daily)
|
300 mg/Day Dexpramipexole
dexpramipexole 150 mg BID (twice daily)
|
|---|---|---|---|---|
|
Part 1: 12-week Double-Blind Treatment
STARTED
|
27
|
23
|
26
|
26
|
|
Part 1: 12-week Double-Blind Treatment
COMPLETED
|
26
|
22
|
26
|
24
|
|
Part 1: 12-week Double-Blind Treatment
NOT COMPLETED
|
1
|
1
|
0
|
2
|
|
Part 2: 4-week Placebo Washout
STARTED
|
97
|
0
|
0
|
0
|
|
Part 2: 4-week Placebo Washout
COMPLETED
|
92
|
0
|
0
|
0
|
|
Part 2: 4-week Placebo Washout
NOT COMPLETED
|
5
|
0
|
0
|
0
|
|
Part 2: 76-week Double-Blind Treatment
STARTED
|
0
|
48
|
0
|
44
|
|
Part 2: 76-week Double-Blind Treatment
COMPLETED
|
0
|
33
|
0
|
30
|
|
Part 2: 76-week Double-Blind Treatment
NOT COMPLETED
|
0
|
15
|
0
|
14
|
Reasons for withdrawal
| Measure |
Placebo Twice Daily
Placebo (PBO) BID (twice daily)
|
50 mg/Day Dexpramipexole
dexpramipexole 25 mg BID (twice daily)
|
150 mg/Day Dexpramipexole
dexpramipexole 75 mg BID (twice daily)
|
300 mg/Day Dexpramipexole
dexpramipexole 150 mg BID (twice daily)
|
|---|---|---|---|---|
|
Part 1: 12-week Double-Blind Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Part 1: 12-week Double-Blind Treatment
Adverse Event
|
1
|
0
|
0
|
1
|
|
Part 1: 12-week Double-Blind Treatment
Physician Decision
|
0
|
1
|
0
|
0
|
|
Part 2: 4-week Placebo Washout
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Part 2: 4-week Placebo Washout
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Part 2: 4-week Placebo Washout
Death
|
3
|
0
|
0
|
0
|
|
Part 2: 76-week Double-Blind Treatment
Withdrawal by Subject
|
0
|
5
|
0
|
4
|
|
Part 2: 76-week Double-Blind Treatment
Adverse Event
|
0
|
1
|
0
|
4
|
|
Part 2: 76-week Double-Blind Treatment
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Part 2: 76-week Double-Blind Treatment
Death
|
0
|
7
|
0
|
5
|
|
Part 2: 76-week Double-Blind Treatment
Inability to attend study visits in person
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg BID for 12 weeks
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
56.01 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.96 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 10.25 • n=21 Participants
|
|
Age, Customized
< 50 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Age, Customized
50 to 65 years
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Customized
> 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
95 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Height
|
170.28 cm
STANDARD_DEVIATION 10.349 • n=5 Participants
|
170.34 cm
STANDARD_DEVIATION 8.209 • n=7 Participants
|
172.22 cm
STANDARD_DEVIATION 12.591 • n=5 Participants
|
174.98 cm
STANDARD_DEVIATION 9.932 • n=4 Participants
|
171.99 cm
STANDARD_DEVIATION 10.471 • n=21 Participants
|
|
Weight
|
74.7 kg
STANDARD_DEVIATION 15.83 • n=5 Participants
|
78.2 kg
STANDARD_DEVIATION 19.89 • n=7 Participants
|
77.4 kg
STANDARD_DEVIATION 18.73 • n=5 Participants
|
82.1 kg
STANDARD_DEVIATION 14.35 • n=4 Participants
|
78.1 kg
STANDARD_DEVIATION 17.18 • n=21 Participants
|
|
Body mass index
|
25.66 kg/m^2
STANDARD_DEVIATION 3.934 • n=5 Participants
|
26.86 kg/m^2
STANDARD_DEVIATION 6.369 • n=7 Participants
|
25.78 kg/m^2
STANDARD_DEVIATION 4.492 • n=5 Participants
|
26.81 kg/m^2
STANDARD_DEVIATION 4.189 • n=4 Participants
|
26.27 kg/m^2
STANDARD_DEVIATION 4.752 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Neutrophils (x10^3/uL) < 1000/uL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Eosinophils (x10^3/uL) > 5000/uL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Hemoglobin (g/dL) < 8 g/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Platelets (x10^3/uL) < 50,000/uL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
White Blood Cell Count (x10^3/uL) < 2000/uL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Creatine Kinase (U/L) >= 10xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Total Bilirubin (mg/dL) > 1.5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
ALT (SGPT) (U/L) > 3xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
AST (SGOT) (U/L) > 3xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Alkaline Phosphatase (U/L) > 1.5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
BUN (mg/dL) > 5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Creatinine (mg/dL) > 3xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Sodium (mEq/L) low < 123 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Sodium (mEq/L) high > 157 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Potassium (mEq/L) Low < 2.5 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Potassium (mEq/L) High > 6.5 mEq/L
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Glucose (mg/dL) Low < 40 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Glucose (mg/dL) High > 250 mg/dL
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Calcium (mg/dL) Low < 7 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Calcium (mg/dL) High > 12.5 mg/dL
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Junctional Rhythm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Atrial Flutter
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Atrial Fibrillation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Supraventricular
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Tachycardia > 100 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Torsades de Pointes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Possible Myocardial Ischemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Acute or Subacute Myocardial Infarction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Possible Myocardial Infarction
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Tachycardia > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Bradycardia < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Block/Sinus Arrest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Other Ventricular Rhythm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 1st Degree A-V Block
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 2nd Degree A-V Block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 3rd Degree A-V Block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Left Bundle Branch Block
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Right Bundle Branch Block
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Pre-excitation (PR < 120 msec)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Prolonged QTcB
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Prolonged QTcF
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Myocardial Ischemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Old Myocardial Infarction
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
U Wave Abnormal U wave present
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Pulse Increase of > 15 bpm from baseline and >= 120
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHg
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Systolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHg
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Diastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Diastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHg
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Pulse Decrease of < -15 bpm from baseline and <= 50
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Body Weight Increase of > 7% lbs from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Body Weight Decrease of < -7% lbs from baseline
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized subjects who had at least 1 post-baseline clinical status evaluation within 7 days of discontinuing study drug
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis ALSFRS-R score. Units for slope are change per month in units on the ALSFRS-R scale.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Slope of ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 12 by Treatment Group
|
-1.278 slope
Interval -1.82 to -0.74
|
-1.885 slope
Interval -2.48 to -1.29
|
-1.165 slope
Interval -1.71 to -0.62
|
-0.878 slope
Interval -1.44 to -0.31
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Randomized subjects who had at least 1 post-baseline clinical status evaluation with 7 days of discontinuing study drug
Slope of change in Upright Vital Capacity (percent predicted upright vital capacity) from Baseline to Week 12. A negative change/slope indicates clinical worsening. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis as percent predicted upright vital capacity. Units for slope are change per month in percent predicted upright vital capacity.
Outcome measures
| Measure |
Placebo
n=27 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=23 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
n=26 Participants
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
n=26 Participants
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 1: Slope of Upright Vital Capacity From Baseline to Week 12 by Treatment Group
|
-4.398 slope
Interval -6.42 to -2.38
|
-4.003 slope
Interval -6.23 to -1.77
|
-2.389 slope
Interval -4.44 to -0.34
|
-3.947 slope
Interval -6.07 to -1.82
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug during the placebo washout.
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo
n=90 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
Hemoglobin (g/dL) < 8 g/dL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
Platelets (x10^3/uL) < 50,000/uL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
White Blood Cell Count (x10^3/uL) < 2000/uL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
Neutrophils (x10^3/uL) < 1000/uL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Hematology
Eosinophils (x10^3/uL) > 5000/uL
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 2, received at least 1 dose of study drug, and had one post BL evaluation during the placebo washout.
Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Outcome measures
| Measure |
Placebo
n=97 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
ALT (SGPT) (U/L) > 3xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
AST (SGOT) (U/L) > 3xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Alkaline Phosphatase (U/L) > 1.5xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
BUN (mg/dL) > 5xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Creatinine (mg/dL) > 3xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Glucose (mg/dL) High > 250 mg/dL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Calcium (mg/dL) Low < 7 mg/dL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Creatine Kinase (U/L) >= 10xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Total Bilirubin (mg/dL) > 1.5xULN
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Sodium (mEq/L) low < 123 mEq/L
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Sodium (mEq/L) high > 157 mEq/L
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Calcium (mg/dL) High > 12.5 mg/dL
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Potassium (mEq/L) Low < 2.5 mEq/L
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Potassium (mEq/L) High > 6.5 mEq/L
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Blood Chemistry Results
Glucose (mg/dL) Low < 40 mg/dL
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1, received at least 1 dose of study drug, and have at least on evaluation post baseline.
Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group.
Outcome measures
| Measure |
Placebo
n=97 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Myocardial Ischemia/Infarction Old Myocardial Infarction
|
4 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Myocardial Ischemia/Infarction Acute or Subacute Myocardial Infarction
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
U Wave Abnormal U wave present
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Sinus Tachycardia > 120 bpm
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Sinus Bradycardia < 40 bpm
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Sinus Block/Sinus Arrest
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Junctional Rhythm
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Atrial Flutter
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Atrial Fibrillation
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Supraventricular
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Tachycardia > 100 bpm
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Torsades de Pointes
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Rhythm Other Ventricular Rhythm
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction 1st Degree A-V Block
|
2 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction 2nd Degree A-V Block
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction 3rd Degree A-V Block
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction Left Bundle Branch Block
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction Right Bundle Branch Block
|
2 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction Pre-excitation (PR < 120 msec)
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction Prolonged QTcB
|
4 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Conduction Prolonged QTcF
|
3 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Myocardial Ischemia/Infarction Myocardial Ischemia
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Myocardial Ischemia/Infarction Possible Myocardial Ischemia
|
2 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings
Myocardial Ischemia/Infarction Possible Myocardial Infarction
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages are based on the number of patients with at least one non-missing post-baseline value in each treatment group.
Outcome measures
| Measure |
Placebo
n=97 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHg
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Diastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHg
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Pulse Increase of > 15 bpm from baseline and >= 120
|
1 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Systolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHg
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Diastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHg
|
2 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Pulse Decrease of < -15 bpm from baseline and <= 50
|
1 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Body Weight Increase of > 7% lbs from baseline
|
0 Participants
|
—
|
—
|
—
|
|
Part 2 Placebo Washout: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Body Weight Decrease of < -7% lbs from baseline
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Randomized subjects who had at least 1 post-baseline clinical status evaluation with 7 days of discontinuing study drug
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. Units are points on the ALSFRS-R score as an absolute change from the baseline of the placebo washout to week 4 of the placebo washout.
Outcome measures
| Measure |
Placebo
n=92 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Absolute Change in ALSFRS-R Total Score
|
-1.2 units on a scale
Standard Error 0.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Randomized subjects who had at least 1 post-baseline clinical status evaluation with 7 days of discontinuing study drug
Absolute change in Upright Vital Capacity From Baseline to Week 4. Units are percent of predicted Upright Vital Capacity. A negative change indicates clinical worsening.
Outcome measures
| Measure |
Placebo
n=89 Participants
PBO BID for 12 weeks
|
50 mg/Day
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Placebo Washout: Absolute Change in Upright Vital Capacity (Percent Predicted) From Baseline to End of Placebo Washout (Week 4)
|
-3.1 units on a scale
Standard Error 0.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 76 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter.
Outcome measures
| Measure |
Placebo
n=48 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
White Blood Cell Count (x10^3/uL) < 2000/uL
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Eosinophils (x10^3/uL) > 5000/uL
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Hemoglobin (g/dL) < 8 g/dL
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Neutrophils (x10^3/uL) < 1000/uL
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group
Platelets (x10^3/uL) < 50,000/uL
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 76 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1 and received at least 1 dose of study drug.
Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter.
Outcome measures
| Measure |
Placebo
n=48 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Creatinine (mg/dL) > 3xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Glucose (mg/dL) High > 250 mg/dL
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Calcium (mg/dL) Low < 7 mg/dL
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Creatine Kinase (U/L) >= 10xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Total Bilirubin (mg/dL) > 1.5xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
ALT (SGPT) (U/L) > 3xULN
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
AST (SGOT) (U/L) > 3xULN
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Alkaline Phosphatase (U/L) > 1.5xULN
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
BUN (mg/dL) > 5xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Sodium (mEq/L) low < 123 mEq/L
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Sodium (mEq/L) high > 157 mEq/L
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Potassium (mEq/L) Low < 2.5 mEq/L
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Potassium (mEq/L) High > 6.5 mEq/L
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Glucose (mg/dL) Low < 40 mg/dL
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group
Calcium (mg/dL) High > 12.5 mg/dL
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 76 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 2, received at least 1 dose of study drug, and had at least one evaluation post baseline.
Number of Participants with Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter.
Outcome measures
| Measure |
Placebo
n=48 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Torsades de Pointes
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 2nd Degree A-V Block
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Right Bundle Branch Block
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Pre-excitation (PR < 120 msec)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Prolonged QTcF
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Possible Myocardial Ischemia
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Acute or Subacute Myocardial Infarction
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
U Wave Abnormal U wave present
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Tachycardia > 120 bpm
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Bradycardia < 40 bpm
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Sinus Block/Sinus Arrest
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Junctional Rhythm
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Atrial Flutter
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Atrial Fibrillation
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Supraventricular
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Tachycardia > 100 bpm
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Rhythm Other Ventricular Rhythm
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 1st Degree A-V Block
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction 3rd Degree A-V Block
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Left Bundle Branch Block
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Conduction Prolonged QTcB
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Myocardial Ischemia
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Old Myocardial Infarction
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Treatment Emergent Potentially Clinically Significant Electrocardiogram (ECG) Findings by Treatment Group
Myocardial Ischemia/Infarction Possible Myocardial Infarction
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 76 weeksPopulation: Safety Population: Data from all enrolled subjects who were randomized in Part 1, received at least 1 dose of study drug, and had at least one post baseline evaluation.
Number of Participants with Potentially Clinically Significant Vital Sign Measurements by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per parameter.
Outcome measures
| Measure |
Placebo
n=48 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Diastolic Blood Pressure Decrease of < -15 mmHg from baseline and <= 50 mmHg
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Body Weight Increase of > 7% lbs from baseline
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Body Weight Decrease of < -7% lbs from baseline
|
14 Participants
|
16 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Systolic Blood Pressure Increase of > 20 mmHg from baseline and >= 180mmHg
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Systolic Blood Pressure Decrease of < -20 mmHg from baseline and <= 90 mmHg
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Diastolic Blood Pressure Increase of > 15 mmHg from baseline and >= 105 mmHg
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Pulse Increase of > 15 bpm from baseline and >= 120
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 2 Double-Blind Treatment: Number of Participants With Potentially Clinically Significant Vital Sign Measurements by Treatment Group
Pulse Decrease of < -15 bpm from baseline and <= 50
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Randomized subjects who had at least 1 post-baseline clinical status evaluation with 7 days of discontinuing study drug
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis ALSFRS-R score. Units for slope are change per month n units on the ALSFRS-R scale.
Outcome measures
| Measure |
Placebo
n=46 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Slope of the ALSFRS-R (ALS Functional Rating Scale With Respiratory Component) From Baseline to Week 28 by Treatment Group
|
-1.284 slope
Interval -1.56 to -1.01
|
-1.021 slope
Interval -1.29 to -0.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of randomized phase of Part 2 to week 28 of randomized phase of Part 2Population: Randomized subjects who had at least 1 post-baseline clinical status evaluation with 7 days of discontinuing study drug.
Slope of Upright Vital Capacity (percent predicted) through Week 28. A negative change indicates clinical worsening. Slope is calculated using a linear mixed effects model with x-axis time in months and y-axis percent predicted upright vital capacity. Units for slope are change per month in percent predicted upright vital capacity.
Outcome measures
| Measure |
Placebo
n=46 Participants
PBO BID for 12 weeks
|
50 mg/Day
n=44 Participants
25 mg dexpramipexole BID for 12 weeks
|
150 mg/Day
75 mg dexpramipexole BID for 12 weeks
|
300 mg/Day
150 mg dexpramipexole BID for 12 weeks
|
|---|---|---|---|---|
|
Part 2 Double-Blind Treatment: Slope of Percent Predicted Upright Vital Capacity From Baseline by Treatment Group
|
-2.452 slope
Interval -3.5 to -1.41
|
-3.067 slope
Interval -4.06 to -2.07
|
—
|
—
|
Adverse Events
Part 1: Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Part 1: Dexpramipexole (50 mg/Day)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 1: Dexpramipexole (150 mg/Day)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Part 1: Dexpramipexole (300 mg/Day)
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Part 2: Placebo Washout
Serious events: 5 serious events
Other events: 46 other events
Deaths: 3 deaths
Part 2: Dexpramipexole (50 mg/Day)
Serious events: 14 serious events
Other events: 46 other events
Deaths: 15 deaths
Part 2: Dexpramipexole (300 mg/Day)
Serious events: 12 serious events
Other events: 41 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=27 participants at risk
Two matching PBO tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (50 mg/Day)
n=23 participants at risk
Two 12.5 mg tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (150 mg/Day)
n=26 participants at risk
Two 37.5 mg tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (300 mg/Day)
n=26 participants at risk
Two 75 mg tablets taken orally twice daily for 12 weeks
|
Part 2: Placebo Washout
n=97 participants at risk
Two matching PBO tablets taken orally twice daily for 4 weeks
|
Part 2: Dexpramipexole (50 mg/Day)
n=48 participants at risk
Two 12.5 mg tablets taken orally twice daily for up to 18 months
|
Part 2: Dexpramipexole (300 mg/Day)
n=44 participants at risk
Two 75 mg tablets taken orally twice daily for up to 18 months
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
INTESTINAL INFARCTION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
2/97 • Number of events 2 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Renal and urinary disorders
URETHRAL OBSTRUCTION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Number of events 2 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Number of events 2 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Number of events 4 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Number of events 2 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Number of events 1 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
Other adverse events
| Measure |
Part 1: Placebo
n=27 participants at risk
Two matching PBO tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (50 mg/Day)
n=23 participants at risk
Two 12.5 mg tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (150 mg/Day)
n=26 participants at risk
Two 37.5 mg tablets taken orally twice daily for 12 weeks
|
Part 1: Dexpramipexole (300 mg/Day)
n=26 participants at risk
Two 75 mg tablets taken orally twice daily for 12 weeks
|
Part 2: Placebo Washout
n=97 participants at risk
Two matching PBO tablets taken orally twice daily for 4 weeks
|
Part 2: Dexpramipexole (50 mg/Day)
n=48 participants at risk
Two 12.5 mg tablets taken orally twice daily for up to 18 months
|
Part 2: Dexpramipexole (300 mg/Day)
n=44 participants at risk
Two 75 mg tablets taken orally twice daily for up to 18 months
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Constipation
|
18.5%
5/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.7%
2/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
6/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
16.7%
8/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
25.0%
11/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.7%
2/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Dry Mouth
|
11.1%
3/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.7%
2/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
15.9%
7/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
14.6%
7/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.7%
2/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.7%
2/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
15.4%
4/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.1%
4/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
10.4%
5/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.4%
5/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
16.7%
8/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
18.2%
8/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
Disease Progression
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
2/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
Fatigue
|
7.4%
2/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.7%
2/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.7%
2/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
2/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
General disorders
Pyrexia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.4%
5/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
10.4%
5/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
12.5%
6/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.4%
5/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.7%
2/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
14.8%
4/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
26.1%
6/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
42.3%
11/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
26.9%
7/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.3%
11/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
27.1%
13/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
25.0%
11/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
25.9%
7/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
17.4%
4/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
19.2%
5/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
19.2%
5/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
13.0%
3/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
22.2%
6/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
21.7%
5/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
26.9%
7/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
23.1%
6/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
7.2%
7/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
31.2%
15/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
15.9%
7/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
1/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Nervous system disorders
Dysarthria
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.7%
2/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.4%
5/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Nervous system disorders
Headache
|
18.5%
5/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
23.1%
6/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
2/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
10.4%
5/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
13.6%
6/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Nervous system disorders
Muscle Contractions Involuntary
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.5%
2/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Nervous system disorders
Muscle Spasticity
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
10.4%
5/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
13.6%
6/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.1%
2/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
12.5%
6/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
18.2%
8/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
13.0%
3/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
20.5%
9/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
2.3%
1/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
6/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.4%
5/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.3%
1/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.8%
1/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
11.5%
3/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
3.1%
3/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
10.4%
5/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
13.6%
6/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
8.3%
4/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.8%
3/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
1.0%
1/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
6.2%
3/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/27 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/23 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/26 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
0.00%
0/97 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
4.2%
2/48 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
9.1%
4/44 • Part 1: up to 12 weeks; Part 2 Placebo washout: up to 4 weeks; Part 2 Treatment period: up to 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER