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Trial · NCT01337986

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEfficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity ScoresVisit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)Per protocol analysisLogMAR ScoreMEAN
PRIMARYEfficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast SensitivityVisit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)Per protocol analysislettersMEAN
PRIMARYDifference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1Visit 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 ScoreMEAN
SECONDARYPercentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity ChartVisit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)Percentages of eyes that improvedNUMBER
SECONDARYPercentage 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 LinePercent of EyesNUMBER
SECONDARYVisual Evoked Potential P100 Latency Per Treatment ArmVisit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)per protocolmillisecondsMEAN
SECONDARYOdds Ratio Quartile of Visual Field IndexVisit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2)Visual Field Index % of normal visionMEAN
SECONDARYChanges 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 protocolFM100 Total Error ScoreMEAN
SECONDARYDalfampridine Effect on Quality of Life Change From Baseline.Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)NEI VFQ percentageMEDIAN
SECONDARYDifference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)per protocolunits on a scaleMEAN
PRIMARYChange From Baseline in Raw Letters by EDTRS 5% Contrast SensitivityVisit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)Intent To Treat Population, scores from morning and afternoon were averaged.lettersMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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