Trial · NCT01328379
Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
NCT01328379, Phase 3, Completed, Acorda Therapeutics; results first posted 2013-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis. Trials, record NCT01328379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01328379
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
- NCT number
- NCT01328379
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 430 participants, actual
- Lead sponsor
- Acorda Therapeutics
- Conditions
- Multiple Sclerosis
- Interventions
- Dalfampridine-ER 5mg, Dalfampridine-ER 10mg, Placebo
- First posted
- 2011-04-04
- Last updated
- 2013-09-05
- Results first posted
- 2013-08-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4) | The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability. A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study. |
| Secondary | Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4) | The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability. A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study. |
| Secondary | Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices. For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. MSWS-12 Score = 100 \* \[(Sum of Items 1-12) - 12\]/48 |
| Secondary | Change From Baseline in MSWS-12 at Visit 2 | Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) | The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices. For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. MSWS-12 Score = 100 \* \[(Sum of Items 1-12) - 12\]/48 |
| Secondary | Change From Baseline in Six-Minute Walk Distance at Visit 2 | Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) | The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet. |
| Secondary | Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3. | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients' health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems). A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3. |
| Secondary | Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3. | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4) | Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment. | feet per second | MEAN |
| SECONDARY | Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4) | Full Analysis Population | feet per second | MEAN |
| SECONDARY | Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | Full Analysis Population | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in MSWS-12 at Visit 2 | Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) | Full Analysis Population | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Six-Minute Walk Distance at Visit 2 | Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period ) | Full Analysis Population | Feet | MEAN |
| SECONDARY | Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3. | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | Full Analysis Population | units on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3. | Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4) | Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Placebo | 0.363 | Standard Error 0.0511 | feet per second | |
| Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Dalfampridine-ER 5mg | 0.423 | Standard Error 0.0470 | feet per second | |
| Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Dalfampridine-ER 10mg | 0.478 | Standard Error 0.0569 | feet per second | |
| Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Placebo | 0.301 | Standard Error 0.0496 | feet per second | |
| Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Dalfampridine-ER 5mg | 0.296 | Standard Error 0.0429 | feet per second | |
| Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW). | Dalfampridine-ER 10mg | 0.391 | Standard Error 0.0513 | feet per second | |
| Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 | Placebo | -8.35 | Standard Error 1.774 | scores on a scale | |
| Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 | Dalfampridine-ER 5mg | -9.73 | Standard Error 1.741 | scores on a scale | |
| Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3 | Dalfampridine-ER 10mg | -11.10 | Standard Error 1.818 | scores on a scale | |
| Change From Baseline in MSWS-12 at Visit 2 | Placebo | -9.48 | Standard Error 1.713 | scores on a scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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 | 143 | |
| Overall Study | STARTED | Dalfampridine-ER 5mg | 144 | |
| Overall Study | STARTED | Dalfampridine-ER 10mg | 143 | |
| Overall Study | COMPLETED | Placebo | 142 | |
| Overall Study | COMPLETED | Dalfampridine-ER 5mg | 144 | |
| Overall Study | COMPLETED | Dalfampridine-ER 10mg | 143 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Dalfampridine-ER 5mg | 0 | |
| Overall Study | NOT COMPLETED | Dalfampridine-ER 10mg | 0 |
Source ClinicalTrials.gov
Adverse events69
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 2 | 143 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dalfampridine-ER 5mg | 5 | 144 | 5 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dalfampridine-ER 10mg | 3 | 142 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 143 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Dalfampridine-ER 5mg | 5 | 144 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Dalfampridine-ER 10mg | 6 | 142 | 6 |
| other | Balance disorder | Nervous system disorders | Placebo | 6 | 143 | 7 |
| other | Balance disorder | Nervous system disorders | Dalfampridine-ER 5mg | 3 | 144 | 3 |
| other | Balance disorder | Nervous system disorders | Dalfampridine-ER 10mg | 2 | 142 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 143 | 8 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dalfampridine-ER 5mg | ||
| Total, all-cause mortality | Dalfampridine-ER 10mg | ||
| Total, other adverse events | Placebo | 77 | 143 |
| Total, other adverse events | Dalfampridine-ER 5mg | 80 | 144 |
| Total, other adverse events | Dalfampridine-ER 10mg | 84 | 142 |
| Total, serious adverse events | Placebo | 0 | 143 |
| Total, serious adverse events | Dalfampridine-ER 5mg | 2 | 144 |
| Total, serious adverse events | Dalfampridine-ER 10mg | 2 | 142 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01328379
GET https://conductscience.org/api/trials/v1/NCT01328379/results?page=2