Trial · NCT01337986
Ampyra for Optic Neuritis in Multiple Sclerosis
NCT01337986, Phase 2, Phase 3, Completed, Washington University School of Medicine; results first posted 2020-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ampyra for Optic Neuritis in Multiple Sclerosis. Trials, record NCT01337986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01337986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ampyra for Optic Neuritis in Multiple Sclerosis
- NCT number
- NCT01337986
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 53 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Multiple Sclerosis, Optic Neuritis
- Interventions
- Dalfampridine/Placebo, Placebo/Dalfampridine
- First posted
- 2011-04-19
- Last updated
- 2020-01-30
- Results first posted
- 2020-01-30
- Limitations and caveats
- Pilot study with relatively small number of patients compared to a phase III study. Cross-over design may be inferior to placebo-controlled parallel cohort study.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Per Protocol Analysis to assess differences in EDTRS 5% Contrast Sensitivity (LogMAR) Scores at visits 2 and 3 Relative to Visit 1 on patients taking Dalfampridine vs Placebo. |
| Primary | Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Per Protocol Analysis to assess difference in number of letters on the EDTRS 5% Contrast Sensitivity (LogMAR) Chart scores at visits 2 and 3 Relative to Visit 1 |
| Primary | Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1 | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Improvement from baseline scores. |
| Primary | Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Change in the number of letters able to read while on Dalfampridine and Placebo relative to their baseline scores. |
| Secondary | Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | |
| Secondary | Percentage of Eyes That Improved by One-line (5 Letters) | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart |
| Secondary | Visual Evoked Potential P100 Latency Per Treatment Arm | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Visual evoked potential 60min P100 latency on dalfampridine vs. placebo. |
| Secondary | Odds Ratio Quartile of Visual Field Index | Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2) | The Visual Field Index (VFI) is a global index that assigns a number between 1% to 100% based on an aggregate percentage of visual function, with 100% being a perfect age-adjusted visual field. Probability of falling in the best quartile for visual field (VFI) measures (Q1), relative to the three next quartiles for worse VFIs (Q2-4), while on Dalfampridine vs Placebo. Due to the clustered observations at different times in a cross-over design, the visual field data is not suited to a normal theory model and should not be expressed as a continuous variable. Thus, a categorical model that uses a multinomial distribution for measurement of 4 categories was selected for proper statistical modeling, with results expressed as odds ratios. |
| Secondary | Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100). | Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - postintervention 1) and Visit 3 (Week 8 - post intervention 2) | Dalfampridine will change color vision Total Error Scores from baseline on the Farnsworth Munsell 100 Hue Sort Test. Farnsworth Munsell 100 Hue Test requires placing 100 color palettes in the correct order based upon color hue. Scores are determined by the frequency and severity of any displacement in the correct order. One error equates to one misplaced hue, by one step or position. An error score greater than 500 indicates virtually no color discrimination. An error score of 0 indicates no errors in ordering the hues. A Total Error Score of 0 to 128 could be seen in a normal population. |
| Secondary | Dalfampridine Effect on Quality of Life Change From Baseline. | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Dalfampridine treatment will result in change in quality of life. The National Eye Institute Visual Function Questionnaire consists of 25 questions characterizing visual function at home and in the community. Score ranges from 100 (best) to 0 (worst). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Per protocol analysis | LogMAR Score | MEAN |
| PRIMARY | Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Per protocol analysis | letters | MEAN |
| PRIMARY | Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1 | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Intent To Treat Population, scores from morning and afternoon were averaged. | 5% Contrast LogMAR Score | MEAN |
| SECONDARY | Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Percentages of eyes that improved | NUMBER | |
| SECONDARY | Percentage of Eyes That Improved by One-line (5 Letters) | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | Proportion as the Percent of Eyes Improved by 1 Line | Percent of Eyes | NUMBER |
| SECONDARY | Visual Evoked Potential P100 Latency Per Treatment Arm | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | per protocol | milliseconds | MEAN |
| SECONDARY | Odds Ratio Quartile of Visual Field Index | Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2) | Visual Field Index % of normal vision | MEAN | |
| SECONDARY | Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100). | Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - postintervention 1) and Visit 3 (Week 8 - post intervention 2) | per protocol | FM100 Total Error Score | MEAN |
| SECONDARY | Dalfampridine Effect on Quality of Life Change From Baseline. | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | NEI VFQ percentage | MEDIAN | |
| SECONDARY | Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1 | Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) | per protocol | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Group B: Dalfampridine | -0.04 | Standard Deviation 0.02 | LogMAR Score | |
| Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Group B: Placebo | -0.06 | Standard Deviation 0.02 | LogMAR Score | |
| Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Group A: Placebo | -0.08 | Standard Deviation 0.02 | LogMAR Score | |
| Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores | Group A: Dalfampridine | -0.06 | Standard Deviation 0.02 | LogMAR Score | |
| Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Group B: Dalfampridine | 2 | Standard Deviation 1 | letters | |
| Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Group B: Placebo | 2 | Standard Deviation 1 | letters | |
| Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Group A: Placebo | 4 | Standard Deviation 1 | letters | |
| Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity | Group A: Dalfampridine | 3 | Standard Deviation 1 | letters | |
| Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1 | Dalfampridine | 0.06 | Standard Deviation 0.02 | 5% Contrast LogMAR Score | |
| Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1 | Placebo | 0.05 | Standard Deviation 0.02 | 5% Contrast LogMAR Score |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group B: Dalfampridine/Placebo | 23 | |
| Overall Study | STARTED | Group A: Placebo/Dalfampridine | 23 | |
| Overall Study | COMPLETED | Group B: Dalfampridine/Placebo | 20 | |
| Overall Study | COMPLETED | Group A: Placebo/Dalfampridine | 18 | |
| Overall Study | NOT COMPLETED | Group B: Dalfampridine/Placebo | 3 | |
| Overall Study | NOT COMPLETED | Group A: Placebo/Dalfampridine | 5 |
Source ClinicalTrials.gov
Adverse events2
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 | Dizziness | Nervous system disorders | Dalfampridine | 4 | 46 | 4 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 46 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalfampridine | 0 | 46 |
| Total, all-cause mortality | Placebo | 0 | 46 |
| Total, other adverse events | Dalfampridine | 4 | 46 |
| Total, other adverse events | Placebo | 0 | 46 |
| Total, serious adverse events | Dalfampridine | 0 | 46 |
| Total, serious adverse events | Placebo | 0 | 46 |
Source ClinicalTrials.gov
Papers33
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalfampridine vs Placebo: deaths from any cause | Trial comparisons |
| Dalfampridine vs Placebo: serious adverse events | 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.
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