Multiple Sclerosis
Conditions
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.
Interventions
BEHAVIORALcognitive and behavioural questionnaires
Sponsors
Hospital General Universitario Gregorio Marañon
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with multiple sclerosis with fampridine treatment
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in speed of processing | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Multiple Sclerosis Fatigue Impact Scale (MSFIS) |
| 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. | Multiple Sclerosis Quality of Life 54 (MSQoL-54) |
Countries
Spain
Contacts
Primary ContactYolanda Higueras, PhD
Backup ContactMaría Luisa Martínez-Ginés, MD
Outcome results
None listed