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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical measures | multiple sclerosis patients in treatment with fampridine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive and behavioural questionnaires | Behavioral |
|
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with multiple sclerosis elegible for fampridine treatment according to drug lable.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yolanda Higueras, PhD | Contact | yolanda.higueras@iisgm.com | ||
| María Luisa Martínez-Ginés, MD | Contact | marisamgines@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Luisa Martínez-Ginés, MD | Neurologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |