Trial · NCT03436199
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
NCT03436199, Phase 3, Completed, Adamas Pharmaceuticals, Inc.; results first posted 2021-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment. Trials, record NCT03436199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03436199
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
- NCT number
- NCT03436199
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- Adamas Pharmaceuticals, Inc.
- Conditions
- Walking Impairment, Multiple Sclerosis
- Interventions
- ADS-5102, 137 mg, ADS-5102, 274 mg, Placebo
- First posted
- 2018-02-19
- Last updated
- 2021-12-21
- Results first posted
- 2021-12-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 16 weeks | 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. |
| Secondary | Timed 25 Foot Walk: Change From Baseline at Week 16 | 16 weeks | 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. |
| Secondary | Timed Up and Go (TUG): Change From Baseline at Week 16 | 16 weeks | 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. |
| Secondary | 2-Minute Walk Test (2MWT): Change From Baseline at Week 16 | 16 weeks | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 16 weeks | Intent-to-treat population | proportion of responders | NUMBER |
| SECONDARY | Timed 25 Foot Walk: Change From Baseline at Week 16 | 16 weeks | Intent-to-treat: subjects with available data at Week 16 | feet/second | LEAST_SQUARES_MEAN |
| SECONDARY | Timed Up and Go (TUG): Change From Baseline at Week 16 | 16 weeks | Intent-to-treat: subjects with available data at Week 16 | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | 2-Minute Walk Test (2MWT): Change From Baseline at Week 16 | 16 weeks | Intent-to-treat: subjects with available data at Week 16 | meters | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | ADS-5102 137 mg | 0.176 | proportion of responders | ||
| 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) | ADS-5102 274 mg | 0.211 | proportion of responders | ||
| 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) | Placebo | 0.113 | proportion of responders | ||
| Timed 25 Foot Walk: Change From Baseline at Week 16 | ADS-5102 137 mg | 0.19 | Standard Error 0.034 | feet/second | |
| Timed 25 Foot Walk: Change From Baseline at Week 16 | ADS-5102 274 mg | 0.19 | Standard Error 0.034 | feet/second | |
| Timed 25 Foot Walk: Change From Baseline at Week 16 | Placebo | 0.07 | Standard Error 0.033 | feet/second | |
| Timed Up and Go (TUG): Change From Baseline at Week 16 | ADS-5102 137 mg | -1.35 | Standard Error 0.384 | seconds | |
| Timed Up and Go (TUG): Change From Baseline at Week 16 | ADS-5102 274 mg | -0.60 | Standard Error 0.415 | seconds | |
| Timed Up and Go (TUG): Change From Baseline at Week 16 | Placebo | -0.56 | Standard Error 0.377 | seconds | |
| 2-Minute Walk Test (2MWT): Change From Baseline at Week 16 | ADS-5102 137 mg | 6.306 | Standard Error 1.2422 | meters |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADS-5102 137 mg | 187 | |
| Overall Study | STARTED | ADS-5102 274 mg | 185 | |
| Overall Study | STARTED | Placebo | 186 | |
| Overall Study | COMPLETED | ADS-5102 137 mg | 165 | |
| Overall Study | COMPLETED | ADS-5102 274 mg | 132 | |
| Overall Study | COMPLETED | Placebo | 174 | |
| Overall Study | NOT COMPLETED | ADS-5102 137 mg | 22 | |
| Overall Study | NOT COMPLETED | ADS-5102 274 mg | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events159
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 | Oedema peripheral | General disorders | ADS-5102 137 mg | 8 | 187 | |
| other | Oedema peripheral | General disorders | ADS-5102 274 mg | 29 | 185 | |
| other | Oedema peripheral | General disorders | Placebo | 1 | 186 | |
| other | Dry mouth | Gastrointestinal disorders | ADS-5102 137 mg | 6 | 187 | |
| other | Dry mouth | Gastrointestinal disorders | ADS-5102 274 mg | 25 | 185 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 2 | 186 | |
| other | Constipation | Gastrointestinal disorders | ADS-5102 137 mg | 8 | 187 | |
| other | Constipation | Gastrointestinal disorders | ADS-5102 274 mg | 15 | 185 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 186 | |
| other | Urinary tract infection | Infections and infestations | ADS-5102 137 mg | 7 | 187 |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADS-5102 137 mg | 0 | 187 |
| Total, all-cause mortality | ADS-5102 274 mg | 0 | 185 |
| Total, all-cause mortality | Placebo | 0 | 186 |
| Total, other adverse events | ADS-5102 137 mg | 105 | 187 |
| Total, other adverse events | ADS-5102 274 mg | 140 | 185 |
| Total, other adverse events | Placebo | 90 | 186 |
| Total, serious adverse events | ADS-5102 137 mg | 5 | 187 |
| Total, serious adverse events | ADS-5102 274 mg | 11 | 185 |
| Total, serious adverse events | Placebo | 1 | 186 |
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/NCT03436199
GET https://conductscience.org/api/trials/v1/NCT03436199/events?page=2