NCT02966808

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	cognitive and behavioural questionnaires

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2016-11-17
• Last updated: 2021-02-10

Locations

1 site across 1 country: Spain