Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. Nevertheless, therapeutic options for this symptom are few and optimal for only some patients.

Detailed Description
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The mechanism of action of fampridine has a direct effect on mobility and it´s based on voltage-dependent potassium channels functioning, causing an improvement of conductivity of action-potential in neurons. This is why nowadays is the only approved drug to treat walking and mobility problems in MS. Results obtained after Phase III randomized clinical trials proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF). There are few studies regarding fampridine effects on symptoms different from mobility. The ENABLE Phase VI study found the first data related with the long-term impact of this treatment in physical and psychological function in patients according to their own perception. Results from this study indicated that, after one year of treatment, patients perceived a sustained benefit in their health, both physical and psychologically.

Official Title
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Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: cognitive and behavioural questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with multiple sclerosis with fampridine treatment Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical measures<br>multiple sclerosis patients in treatment with fampridine | Behavioral: cognitive and behavioural questionnaires<br> <br> * Other names: PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speed of processing | Symbol Digit Modality Test (SDMT) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. | 
| change in attention | Paced Auditory Serial Addition Test (PASAT) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. | 
| change in walking ability | Timed 25 walking feet (T25WF) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. | 
| change in perception of walking ability | Multiple Sclerosis Walking Scale 12 (MSWS12) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fatigue | Multiple Sclerosis Fatigue Impact Scale (MSFIS) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. | 
| change in quality of life | Multiple Sclerosis Quality of Life 54 (MSQoL-54) | change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment. |