Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Hospital General Universitario Gregorio Marañon
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in speed of processing
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
María Luisa Martinez Gines
Medical Doctor in Neurology
Hospital General Universitario Gregorio Marañon
Eligibility Criteria
Inclusion Criteria
- •patients with multiple sclerosis with fampridine treatment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in speed of processing
Time Frame: 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.
Symbol Digit Modality Test (SDMT)
change in attention
Time Frame: 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.
Paced Auditory Serial Addition Test (PASAT)
change in walking ability
Time Frame: 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.
Timed 25 walking feet (T25WF)
change in perception of walking ability
Time Frame: 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.
Multiple Sclerosis Walking Scale 12 (MSWS12)
Secondary Outcomes
- change in fatigue(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(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.)