Trial Outcomes & Findings for A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment (NCT NCT03567057)
NCT ID: NCT03567057
Last Updated: 2022-01-18
Results Overview
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
424 participants
Primary outcome timeframe
Through study completion, an average of 1 year.
Results posted on
2022-01-18
Participant Flow
Participant milestones
| Measure |
Placebo/274 mg ADS-5102
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Overall Study
STARTED
|
159
|
151
|
114
|
|
Overall Study
COMPLETED
|
64
|
64
|
68
|
|
Overall Study
NOT COMPLETED
|
95
|
87
|
46
|
Reasons for withdrawal
| Measure |
Placebo/274 mg ADS-5102
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
56
|
53
|
28
|
|
Overall Study
Withdrawal by Subject
|
22
|
24
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
2
|
|
Overall Study
COVID-19 pandemic
|
4
|
3
|
0
|
|
Overall Study
Non-compliance with study drug
|
4
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Unstable medical condition
|
1
|
0
|
0
|
|
Overall Study
Medical history event
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Baseline characteristics by cohort
| Measure |
Placebo/274 mg ADS-5102
n=159 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=114 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 9.12 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 9.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
360 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Baseline T25FW
<Median of enrolled population (9.4 seconds)
|
63 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
206 Participants
n=4 Participants
|
|
Baseline T25FW
>Median of enrolled population (9.4 seconds)
|
96 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Baseline T25FW
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 year.The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=159 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=114 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Number of Patients With Adverse Events
|
122 Participants
|
116 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified intent-to-treat: subjects with available data
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=159 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=113 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed 25-Foot Walk (Feet/Second) (Baseline Value)
|
2.43 feet/second
Standard Deviation 0.853
|
2.68 feet/second
Standard Deviation 0.840
|
2.66 feet/second
Standard Deviation 0.878
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Modified intent-to-treat: subjects with available data
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=84 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=89 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=74 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
|
2.50 feet/second
Standard Deviation 0.832
|
2.72 feet/second
Standard Deviation 0.969
|
2.71 feet/second
Standard Deviation 0.957
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Modified intent-to-treat: subjects with available data
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=58 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=57 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=59 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
|
2.35 feet/second
Standard Deviation 0.900
|
2.68 feet/second
Standard Deviation 1.055
|
2.65 feet/second
Standard Deviation 0.996
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified intent-to-treat population: subjects with available data
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=159 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=113 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed up and go (Baseline Value)
|
17.60 seconds
Standard Deviation 8.516
|
16.89 seconds
Standard Deviation 17.536
|
16.80 seconds
Standard Deviation 10.652
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Modified intent-to-treat population: subjects with available data
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=84 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=88 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=74 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed up and go (Week 24 Value)
|
17.39 seconds
Standard Deviation 9.466
|
15.36 seconds
Standard Deviation 9.109
|
16.89 seconds
Standard Deviation 11.649
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Modified intent-to-treat population: subjects with available data
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=57 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=57 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=59 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Timed up and go (Week 52 Value)
|
18.68 seconds
Standard Deviation 11.710
|
15.92 seconds
Standard Deviation 11.820
|
17.37 seconds
Standard Deviation 12.311
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified intent-to-treat: subjects with available data
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=159 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=150 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=112 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
2-Minute Walk Test (Baseline Value)
|
80.26 meters
Standard Deviation 31.899
|
89.99 meters
Standard Deviation 31.679
|
87.31 meters
Standard Deviation 31.351
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Modified intent-to-treat: subjects with available data
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=83 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=87 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=71 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
2-Minute Walk Test (Week 24 Value)
|
81.48 meters
Standard Deviation 31.653
|
87.99 meters
Standard Deviation 34.195
|
92.03 meters
Standard Deviation 38.371
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Modified intent-to-treat: subjects with available data
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Outcome measures
| Measure |
Placebo/274 mg ADS-5102
n=58 Participants
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=55 Participants
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=57 Participants
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
2-Minute Walk Test (Week 52 Value)
|
77.45 meters
Standard Deviation 34.147
|
89.18 meters
Standard Deviation 36.707
|
89.14 meters
Standard Deviation 37.295
|
Adverse Events
Placebo/274 mg ADS-5102
Serious events: 20 serious events
Other events: 122 other events
Deaths: 1 deaths
137 mg ADS-5102/274 mg ADS-5102
Serious events: 20 serious events
Other events: 116 other events
Deaths: 0 deaths
274 mg ADS-5102/274 mg ADS-5102
Serious events: 7 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/274 mg ADS-5102
n=159 participants at risk
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 participants at risk
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=114 participants at risk
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.9%
3/159 • Approximately 1 year.
|
1.3%
2/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Encephalopathy
|
0.63%
1/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Seizure
|
0.00%
0/159 • Approximately 1 year.
|
1.3%
2/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Syncope
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Nervous system disorders
Uhthoff's phenomenon
|
0.63%
1/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Dysarthria
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Generalized tonic-clonic seizure
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Nervous system disorders
Status epilepticus
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Cellulitis
|
1.9%
3/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
1/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Infections and infestations
Sepsis
|
0.63%
1/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Infections and infestations
Pharyngeal abscess
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Rectal abscess
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.63%
1/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Psychiatric disorders
Catatonia
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Psychiatric disorders
Hallucination, visual
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Psychiatric disorders
Mental status changes
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Vascular disorders
Deep vein thrombosis
|
0.63%
1/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Vascular disorders
Hypotension
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/159 • Approximately 1 year.
|
0.00%
0/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
0.00%
0/114 • Approximately 1 year.
|
Other adverse events
| Measure |
Placebo/274 mg ADS-5102
n=159 participants at risk
Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
137 mg ADS-5102/274 mg ADS-5102
n=151 participants at risk
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
|
274 mg ADS-5102/274 mg ADS-5102
n=114 participants at risk
Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303
|
|---|---|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
6.9%
11/159 • Approximately 1 year.
|
5.3%
8/151 • Approximately 1 year.
|
7.0%
8/114 • Approximately 1 year.
|
|
Nervous system disorders
Dizziness
|
5.0%
8/159 • Approximately 1 year.
|
5.3%
8/151 • Approximately 1 year.
|
2.6%
3/114 • Approximately 1 year.
|
|
Nervous system disorders
Headache
|
3.1%
5/159 • Approximately 1 year.
|
4.6%
7/151 • Approximately 1 year.
|
5.3%
6/114 • Approximately 1 year.
|
|
Nervous system disorders
Balance disorder
|
5.0%
8/159 • Approximately 1 year.
|
1.3%
2/151 • Approximately 1 year.
|
0.88%
1/114 • Approximately 1 year.
|
|
General disorders
Oedema peripheral
|
17.6%
28/159 • Approximately 1 year.
|
11.3%
17/151 • Approximately 1 year.
|
8.8%
10/114 • Approximately 1 year.
|
|
General disorders
Peripheral swelling
|
5.7%
9/159 • Approximately 1 year.
|
2.6%
4/151 • Approximately 1 year.
|
1.8%
2/114 • Approximately 1 year.
|
|
Infections and infestations
Urinary tract infection
|
10.1%
16/159 • Approximately 1 year.
|
9.9%
15/151 • Approximately 1 year.
|
13.2%
15/114 • Approximately 1 year.
|
|
Psychiatric disorders
Hallucination, visual
|
4.4%
7/159 • Approximately 1 year.
|
7.3%
11/151 • Approximately 1 year.
|
3.5%
4/114 • Approximately 1 year.
|
|
Psychiatric disorders
Insomnia
|
3.1%
5/159 • Approximately 1 year.
|
6.6%
10/151 • Approximately 1 year.
|
4.4%
5/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Dry mouth
|
8.2%
13/159 • Approximately 1 year.
|
11.9%
18/151 • Approximately 1 year.
|
1.8%
2/114 • Approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
9.4%
15/159 • Approximately 1 year.
|
6.0%
9/151 • Approximately 1 year.
|
4.4%
5/114 • Approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
6.3%
10/159 • Approximately 1 year.
|
11.9%
18/151 • Approximately 1 year.
|
7.0%
8/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
8.8%
14/159 • Approximately 1 year.
|
10.6%
16/151 • Approximately 1 year.
|
14.9%
17/114 • Approximately 1 year.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/159 • Approximately 1 year.
|
0.66%
1/151 • Approximately 1 year.
|
5.3%
6/114 • Approximately 1 year.
|
Additional Information
Head, Regulatory Affairs
Adamas Pharmaceuticals, Inc.
Phone: +1 (510) 450-3500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place