Trial · NCT01444300
Dalfampridine for Imbalance in Multiple Sclerosis
NCT01444300, Phase 2, Completed, Oregon Health and Science University; results first posted 2014-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dalfampridine for Imbalance in Multiple Sclerosis. Trials, record NCT01444300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01444300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dalfampridine for Imbalance in Multiple Sclerosis
- NCT number
- NCT01444300
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Multiple Sclerosis, Fatigue
- Interventions
- Dalfampridine, Placebo
- First posted
- 2011-09-30
- Last updated
- 2014-06-16
- Results first posted
- 2014-06-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Automatic Postural Response (APR )Latency | Baseline to 12 weeks | Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of \~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects. |
| Secondary | Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores | Baseline to 12 weeks | The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence. |
| Secondary | Change in Timed 25 Foot Walking Speed | Baseline to 12 weeks |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Automatic Postural Response (APR )Latency | Baseline to 12 weeks | milliseconds | MEAN | |
| SECONDARY | Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores | Baseline to 12 weeks | Scores on a scale | MEAN | |
| SECONDARY | Change in Timed 25 Foot Walking Speed | Baseline to 12 weeks | seconds | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Automatic Postural Response (APR )Latency | Dalfampridine | 5.71 | Standard Deviation 16.2 | milliseconds | |
| Change in Automatic Postural Response (APR )Latency | Placebo | 4.58 | Standard Deviation 23.0 | milliseconds | |
| Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores | Dalfampridine | 1.30 | Standard Deviation 9.02 | Scores on a scale | |
| Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores | Placebo | 0.41 | Standard Deviation 10.7 | Scores on a scale | |
| Change in Timed 25 Foot Walking Speed | Dalfampridine | 0.26 | Standard Deviation 0.78 | seconds | |
| Change in Timed 25 Foot Walking Speed | Placebo | 0.39 | Standard Deviation 1.45 | seconds |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalfampridine | 12 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Dalfampridine | 8 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Dalfampridine | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Insomnia | Nervous system disorders | Dalfampridine | 4 | 12 | 4 |
| other | Insomnia | Nervous system disorders | Placebo | 0 | 12 | 0 |
| other | Nausea | Gastrointestinal disorders | Dalfampridine | 5 | 12 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 12 | 0 |
| other | Muscle weakness | Musculoskeletal and connective tissue disorders | Dalfampridine | 2 | 12 | 2 |
| other | Muscle weakness | Musculoskeletal and connective tissue disorders | Placebo | 6 | 12 | 6 |
| other | Balance problems | Musculoskeletal and connective tissue disorders | Dalfampridine | 2 | 12 | 2 |
| other | Balance problems | Musculoskeletal and connective tissue disorders | Placebo | 4 | 12 | 4 |
| other | Dizziness | Nervous system disorders | Dalfampridine | 3 | 12 | 3 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 12 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalfampridine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dalfampridine | 9 | 12 |
| Total, other adverse events | Placebo | 10 | 12 |
| Total, serious adverse events | Dalfampridine | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 12 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dalfampridine vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01444300
GET https://conductscience.org/api/trials/v1/NCT01444300/registered