Trial · NCT03567057
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
NCT03567057, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2022-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment. Trials, record NCT03567057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03567057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
- NCT number
- NCT03567057
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 424 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Multiple Sclerosis, Walking Impairment
- Interventions
- ADS-5102, 274 mg
- First posted
- 2018-06-25
- Last updated
- 2022-01-18
- Results first posted
- 2022-01-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events | 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. |
| Secondary | Timed 25-Foot Walk (Feet/Second) (Baseline Value) | Baseline | 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. |
| Secondary | Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | 24 weeks | 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. |
| Secondary | Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | 52 weeks | 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. |
| Secondary | Timed up and go (Baseline Value) | Baseline | 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. |
| Secondary | Timed up and go (Week 24 Value) | 24 weeks | 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. |
| Secondary | Timed up and go (Week 52 Value) | 52 weeks | 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. |
| Secondary | 2-Minute Walk Test (Baseline Value) | Baseline | 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. |
| Secondary | 2-Minute Walk Test (Week 24 Value) | 24 weeks | 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. |
| Secondary | 2-Minute Walk Test (Week 52 Value) | 52 weeks | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events | Through study completion, an average of 1 year. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Timed 25-Foot Walk (Feet/Second) (Baseline Value) | Baseline | Modified intent-to-treat: subjects with available data | feet/second | MEAN |
| SECONDARY | Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | 24 weeks | Modified intent-to-treat: subjects with available data | feet/second | MEAN |
| SECONDARY | Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | 52 weeks | Modified intent-to-treat: subjects with available data | feet/second | MEAN |
| SECONDARY | Timed up and go (Baseline Value) | Baseline | Modified intent-to-treat population: subjects with available data | seconds | MEAN |
| SECONDARY | Timed up and go (Week 24 Value) | 24 weeks | Modified intent-to-treat population: subjects with available data | seconds | MEAN |
| SECONDARY | Timed up and go (Week 52 Value) | 52 weeks | Modified intent-to-treat population: subjects with available data | seconds | MEAN |
| SECONDARY | 2-Minute Walk Test (Baseline Value) | Baseline | Modified intent-to-treat: subjects with available data | meters | MEAN |
| SECONDARY | 2-Minute Walk Test (Week 24 Value) | 24 weeks | Modified intent-to-treat: subjects with available data | meters | MEAN |
| SECONDARY | 2-Minute Walk Test (Week 52 Value) | 52 weeks | Modified intent-to-treat: subjects with available data | meters | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events | Placebo/274 mg ADS-5102 | 122 | Participants | ||
| Number of Patients With Adverse Events | 137 mg ADS-5102/274 mg ADS-5102 | 116 | Participants | ||
| Number of Patients With Adverse Events | 274 mg ADS-5102/274 mg ADS-5102 | 86 | Participants | ||
| Timed 25-Foot Walk (Feet/Second) (Baseline Value) | Placebo/274 mg ADS-5102 | 2.43 | Standard Deviation 0.853 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Baseline Value) | 137 mg ADS-5102/274 mg ADS-5102 | 2.68 | Standard Deviation 0.840 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Baseline Value) | 274 mg ADS-5102/274 mg ADS-5102 | 2.66 | Standard Deviation 0.878 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | Placebo/274 mg ADS-5102 | 2.50 | Standard Deviation 0.832 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | 137 mg ADS-5102/274 mg ADS-5102 | 2.72 | Standard Deviation 0.969 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | 274 mg ADS-5102/274 mg ADS-5102 | 2.71 | Standard Deviation 0.957 | feet/second | |
| Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | Placebo/274 mg ADS-5102 | 2.35 | Standard Deviation 0.900 | feet/second |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/274 mg ADS-5102 | 159 | |
| Overall Study | STARTED | 137 mg ADS-5102/274 mg ADS-5102 | 151 | |
| Overall Study | STARTED | 274 mg ADS-5102/274 mg ADS-5102 | 114 | |
| Overall Study | COMPLETED | Placebo/274 mg ADS-5102 | 64 | |
| Overall Study | COMPLETED | 137 mg ADS-5102/274 mg ADS-5102 | 64 | |
| Overall Study | COMPLETED | 274 mg ADS-5102/274 mg ADS-5102 | 68 | |
| Overall Study | NOT COMPLETED | Placebo/274 mg ADS-5102 | 95 | |
| Overall Study | NOT COMPLETED | 137 mg ADS-5102/274 mg ADS-5102 | 87 | |
| Overall Study | NOT COMPLETED | 274 mg ADS-5102/274 mg ADS-5102 | 46 |
Source ClinicalTrials.gov
Adverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Multiple sclerosis relapse | Nervous system disorders | Placebo/274 mg ADS-5102 | 11 | 159 | |
| other | Multiple sclerosis relapse | Nervous system disorders | 137 mg ADS-5102/274 mg ADS-5102 | 8 | 151 | |
| other | Multiple sclerosis relapse | Nervous system disorders | 274 mg ADS-5102/274 mg ADS-5102 | 8 | 114 | |
| other | Dizziness | Nervous system disorders | Placebo/274 mg ADS-5102 | 8 | 159 | |
| other | Dizziness | Nervous system disorders | 137 mg ADS-5102/274 mg ADS-5102 | 8 | 151 | |
| other | Dizziness | Nervous system disorders | 274 mg ADS-5102/274 mg ADS-5102 | 3 | 114 | |
| other | Headache | Nervous system disorders | Placebo/274 mg ADS-5102 | 5 | 159 | |
| other | Headache | Nervous system disorders | 137 mg ADS-5102/274 mg ADS-5102 | 7 | 151 | |
| other | Headache | Nervous system disorders | 274 mg ADS-5102/274 mg ADS-5102 | 6 | 114 | |
| other | Balance disorder | Nervous system disorders | Placebo/274 mg ADS-5102 | 8 | 159 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/274 mg ADS-5102 | 1 | 159 |
| Total, all-cause mortality | 137 mg ADS-5102/274 mg ADS-5102 | 0 | 151 |
| Total, all-cause mortality | 274 mg ADS-5102/274 mg ADS-5102 | 0 | 114 |
| Total, other adverse events | Placebo/274 mg ADS-5102 | 122 | 159 |
| Total, other adverse events | 137 mg ADS-5102/274 mg ADS-5102 | 116 | 151 |
| Total, other adverse events | 274 mg ADS-5102/274 mg ADS-5102 | 86 | 114 |
| Total, serious adverse events | Placebo/274 mg ADS-5102 | 20 | 159 |
| Total, serious adverse events | 137 mg ADS-5102/274 mg ADS-5102 | 20 | 151 |
| Total, serious adverse events | 274 mg ADS-5102/274 mg ADS-5102 | 7 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03567057
GET https://conductscience.org/api/trials/v1/NCT03567057/results?page=2