Trial Outcomes & Findings for Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment (NCT NCT03436199)
NCT ID: NCT03436199
Last Updated: 2021-12-21
Results Overview
The T25FW 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. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
16 weeks
Results posted on
2021-12-21
Participant Flow
Participant milestones
| Measure |
ADS-5102 137 mg
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Overall Study
STARTED
|
187
|
185
|
186
|
|
Overall Study
COMPLETED
|
165
|
132
|
174
|
|
Overall Study
NOT COMPLETED
|
22
|
53
|
12
|
Reasons for withdrawal
| Measure |
ADS-5102 137 mg
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
40
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Could not return to clinic
|
1
|
0
|
0
|
|
Overall Study
Withdrawn per physician
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
Baseline characteristics by cohort
| Measure |
ADS-5102 137 mg
n=187 Participants
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=185 Participants
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=186 Participants
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
Total
n=558 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 9.27 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 9.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
473 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Time since diagnosis of multiple sclerosis
|
15.99 years
STANDARD_DEVIATION 9.862 • n=5 Participants
|
15.97 years
STANDARD_DEVIATION 9.655 • n=7 Participants
|
15.85 years
STANDARD_DEVIATION 9.478 • n=5 Participants
|
15.94 years
STANDARD_DEVIATION 9.649 • n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat population
The T25FW 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. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Outcome measures
| Measure |
ADS-5102 137 mg
n=187 Participants
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=185 Participants
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=186 Participants
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis)
|
0.176 proportion of responders
|
0.211 proportion of responders
|
0.113 proportion of responders
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat: subjects with available data at Week 16
The T25FW 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. For this outcome measure, the result is reported as or speed (feet per second). Improvement is indicated by an increase in speed.
Outcome measures
| Measure |
ADS-5102 137 mg
n=167 Participants
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=135 Participants
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=176 Participants
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Timed 25 Foot Walk: Change From Baseline at Week 16
|
0.19 feet/second
Standard Error 0.034
|
0.19 feet/second
Standard Error 0.034
|
0.07 feet/second
Standard Error 0.033
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat: subjects with available data at Week 16
The TUG 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 |
ADS-5102 137 mg
n=168 Participants
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=136 Participants
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=176 Participants
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Timed Up and Go (TUG): Change From Baseline at Week 16
|
-1.35 seconds
Standard Error 0.384
|
-0.60 seconds
Standard Error 0.415
|
-0.56 seconds
Standard Error 0.377
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intent-to-treat: subjects with available data at Week 16
The 2MWT 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 |
ADS-5102 137 mg
n=167 Participants
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=136 Participants
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=176 Participants
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
2-Minute Walk Test (2MWT): Change From Baseline at Week 16
|
6.306 meters
Standard Error 1.2422
|
5.692 meters
Standard Error 1.3537
|
2.163 meters
Standard Error 1.2158
|
Adverse Events
ADS-5102 137 mg
Serious events: 5 serious events
Other events: 105 other events
Deaths: 0 deaths
ADS-5102 274 mg
Serious events: 11 serious events
Other events: 140 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADS-5102 137 mg
n=187 participants at risk
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=185 participants at risk
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=186 participants at risk
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.53%
1/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/187 • 18 weeks
|
1.1%
2/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.53%
1/187 • 18 weeks
|
0.00%
0/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.53%
1/187 • 18 weeks
|
0.00%
0/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.53%
1/187 • 18 weeks
|
0.00%
0/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/187 • 18 weeks
|
0.00%
0/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Vascular disorders
Hypertension
|
0.53%
1/187 • 18 weeks
|
0.00%
0/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
Other adverse events
| Measure |
ADS-5102 137 mg
n=187 participants at risk
ADS-5102, 137 mg: Oral capsules to be administered once daily at bedtime
|
ADS-5102 274 mg
n=185 participants at risk
ADS-5102, 274 mg: Oral capsules to be administered once daily at bedtime
|
Placebo
n=186 participants at risk
placebo capsules
Placebo: Oral capsules to be administered once daily at bedtime
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
4.3%
8/187 • 18 weeks
|
15.7%
29/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
6/187 • 18 weeks
|
13.5%
25/185 • 18 weeks
|
1.1%
2/186 • 18 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
8/187 • 18 weeks
|
8.1%
15/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.7%
7/187 • 18 weeks
|
8.6%
16/185 • 18 weeks
|
10.2%
19/186 • 18 weeks
|
|
Psychiatric disorders
Insomnia
|
1.6%
3/187 • 18 weeks
|
7.0%
13/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
8/187 • 18 weeks
|
8.6%
16/185 • 18 weeks
|
7.0%
13/186 • 18 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
7/187 • 18 weeks
|
2.2%
4/185 • 18 weeks
|
3.8%
7/186 • 18 weeks
|
|
Nervous system disorders
Dizziness
|
2.7%
5/187 • 18 weeks
|
4.3%
8/185 • 18 weeks
|
2.2%
4/186 • 18 weeks
|
|
Nervous system disorders
Tremor
|
1.1%
2/187 • 18 weeks
|
4.3%
8/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
General disorders
Fatigue
|
3.2%
6/187 • 18 weeks
|
4.3%
8/185 • 18 weeks
|
2.7%
5/186 • 18 weeks
|
|
General disorders
Peripheral swelling
|
0.53%
1/187 • 18 weeks
|
3.2%
6/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
4/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
3.8%
7/186 • 18 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
3/187 • 18 weeks
|
3.8%
7/185 • 18 weeks
|
2.2%
4/186 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/187 • 18 weeks
|
3.8%
7/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.53%
1/187 • 18 weeks
|
3.2%
6/185 • 18 weeks
|
1.1%
2/186 • 18 weeks
|
|
Eye disorders
Vision blurred
|
1.1%
2/187 • 18 weeks
|
4.3%
8/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/187 • 18 weeks
|
3.2%
6/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.53%
1/187 • 18 weeks
|
3.2%
6/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Infections and infestations
Sinusitis
|
0.53%
1/187 • 18 weeks
|
1.1%
2/185 • 18 weeks
|
3.2%
6/186 • 18 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
4/187 • 18 weeks
|
0.54%
1/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Nervous system disorders
Headache
|
2.1%
4/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
2.2%
4/186 • 18 weeks
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.1%
2/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
1.6%
3/186 • 18 weeks
|
|
Nervous system disorders
Balance disorder
|
0.53%
1/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
General disorders
Gait disturbance
|
1.1%
2/187 • 18 weeks
|
2.2%
4/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Psychiatric disorders
Hallucinations, visual
|
2.1%
4/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/187 • 18 weeks
|
3.2%
6/185 • 18 weeks
|
1.1%
2/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
3/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
0.00%
0/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
4/187 • 18 weeks
|
1.6%
3/185 • 18 weeks
|
1.1%
2/186 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.53%
1/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
1.6%
3/186 • 18 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.1%
4/187 • 18 weeks
|
1.1%
2/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/187 • 18 weeks
|
2.2%
4/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
1/187 • 18 weeks
|
2.2%
4/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
|
Vascular disorders
Hypertension
|
1.1%
2/187 • 18 weeks
|
2.7%
5/185 • 18 weeks
|
1.6%
3/186 • 18 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
2/187 • 18 weeks
|
2.2%
4/185 • 18 weeks
|
0.54%
1/186 • 18 weeks
|
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