Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS).
Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine responder is a PwMS with an improvement in the judgment of the practitioner.

Persons who have been diagnosed as Multiple Sclerosis according to Mc Donald Criteria : person with Multiple Sclerosis (PwMS).
Fampridine was prescribed according to the guidelines issued by the French National Security Agency of Medicines and Health Products (ANSM) at the dose of 10 mg twice a day. According to official ANSM guidelines, the prescription is initially limited to 2 weeks of therapy, at which point a new assessment is performed by the medical practitioner to evaluate the clinical benefits. Fampridine non responder is a PwMS without any improvement in the judgment of the practitioner.

Multiple Sclerosis

Fampridine

CHU Jean Minjoz

Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.

Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances

The 6MWT assessed the submaximal level of functional capacity. It was realized according to the recommendation of the American Thoracic Society. 6MWT instructions were read prior to each walk. Participants used his/her typical assistive device and walked around a circuit with 24-meters longer. If necessary, they were allowed to have a rest period and encouragement phrases were used each 30 seconds.

Both semantic and phonological verbal fluencies were assessed in a quiet room. Semantic fluency was measured by asking patients to provide as many animal names as possible in 120 s. Different kinds of one sort of animal were accepted (e.g. kinds of birds or fish). Phonological fluency was measured by asking patients to provide as many words as possible beginning with the letter 'P' in 120 s. They were informed that proper nouns and words with the same stem would not be counted (e.g. pen, pencil). Patients were instructed to avoid repetitions.

The SDMT has a key at the top of the page with numbers and symbols; participants are required to refer to the key to correctly decode several lines of symbols. After completing sample items correctly, participants are timed for 90 s and the total number correct is their raw score. Only correct answers were account to the final score.

The FIS is a 40-item Standardized questionnaire validated for MS. For our study, we used the validated French version of the FIS in MS, called "EMIF-SEP". The EMIF-SEP is composed of 40 items organized into four dimensions (cognitive, physical, social role and psychological dimensions) with each items rated on a four point scale (4=it's always true, 3=it's sometimes true, 2=it's sometimes false, 1=it's always false) and the total fatigue scores are standardized from 0 (meaning no fatigue) to 100 (meaning high degree of fatigue). The forty items are divided into the four dimensions: cognitive (10 items), physical (14 items), social role (13 items) and psychological (4 items). Each dimension score was also standardized as a percentage like total score.

The FSS is a method of evaluating fatigue in PwMS and other conditions, including chronic fatigue immune dysfunction syndrome and systemic lupus erythematosus. The FSS is designed to differentiate fatigue from clinical depression because both share some of the same symptoms. The FSS questionnaire is composed of 9 statements related to patients' subjective perception of fatigue and its consequences on everyday activities. Patients are asked to rate their level of agreement (toward 7) or disagreement (toward 0) with the 9 statements.

The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item.

The PERSEPP scale was used to evaluate the HRQoL of patients with MS (Baroin et al. 2013). This scale takes into account several aspects of HRQoL distributed across 66 items (described below) and includes relapse phases. Each item contains 6 response types according to a Likert scale where "0" was "strongly disagree" and "5" was "strongly agree". The PERSEPP scale has been validated in the French language

The physical activity in real-life condition was measured with an ActiGraph, model wGT3X (Actigraph corp, USA), consistent with previous research on validating accelerometer output in PwMS. The accelerometer was sampled at 30 Hz and values were expressed as number of counts per minute. Participants were instructed to wear the accelerometer on an elastic belt around the waist (i.e. near to the center of displacement of body mass) located above the hip at the non-dominant side ; to wear it for a 7-day period (including a weekend); and to wear it for the whole day from getting out of bed in the morning until getting into bed in the evening. These instructions were summarized in a memo and given to participants.

According with the recommendation of Cutter et al., participants were asked to walk on a 25 feet (7.62 m) distance. After appropriate instructions and familiarization, participants were asked to perform three gait tasks: walking at their self-selected comfortable speed .

The TUG is a clinical test to assess the level of gait and balance. For its realization, a 47-cm-high chair with arm- and backrest was used. The 3-meters distance was marked with a tape on the floor and a cone marked the turning point. Participants were instructed to get up from the chair, walk 3 meters, turn around the cone and come back to sit on the chair. Participants were encouraged to walk as quickly as possible with safety consistency. After a familiarization trial, the TUG was performed twice. A third trial was applied if a difference of 10% was found between the two first trials. The mean value computed from the two closest trials was taken into account.

Centre Hospitalier Universitaire de Besancon

Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.

Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks

Group B: Dalfampridine/Placebo

Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.

Group A: Placebo/Dalfampridine

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

MS Subtype

Clinical Episodes of ON

Baseline 5% Sloan Chart

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.

Group B: Dalfampridine

Group B: Placebo

Group A: Placebo

Group A: Dalfampridine

Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores

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

Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity

Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Improvement from baseline scores.

Patient Assessments while on Dalfampridine

Dalfampridine

Placebo

Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1

Improvement while on Dalfampridine (not placebo)

Improvement while on Placebo (not dalfampridine)

Improvement when taking Dalfampridine or Placebo (improvement with any treatment)

Both

None

Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart

Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart

No Improvement on Dalfampridine or Placebo

Neither

Percentage of Eyes That Improved by One-line (5 Letters)

Visual evoked potential 60min P100 latency on dalfampridine vs. placebo.

Visual Evoked Potential P100 Latency Per Treatment Arm

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.

Weeks 1-3 Dalfampridine 10 mg Twice Daily, Weeks 6-8 Placebo Twice Daily

Dalfampridine Then Placebo

Weeks 1-3 Placebo Twice Daily, Weeks 6-8 Dalfampridine 10 mg Twice Daily

Placebo Then Dalfampridine

Odds Ratio Quartile of Visual Field Index

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.

Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100).

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).

Dalfampridine Effect on Quality of Life Change From Baseline.

Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1 on Dalfampridine vs Placebo. Pelli-Robson is scored based upon the numbers read on the chart converted to LogMAR units. The scale is 0.00 (worst) to 2.35 (best).

Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1

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.

Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity

Overall Study

Robert Naismith, MD

Participants assigned to received dalfampridine.

Participants assigned to received placebo.

Optic Neuritis

Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.

Dalfampridine/Placebo

Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.

Placebo/Dalfampridine

John L. Trotter MS Center, Washington University School of Medicine & Barnes Jewish Hospital

optic neuritis/kali

Short and Long Term Multiple Outcomes in Persons With Multiple Sclerosis Treated by Fampridine.

Ampyra for Optic Neuritis in Multiple Sclerosis

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