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

Hospital General Universitario Gregorio Marañon

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Behavioral: cognitive and behavioural questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02966808

RETROFAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with multiple sclerosis with fampridine treatment

Exclusion criteria

• none

Trial design

50 participants in 1 patient group

Clinical measures

Description:

multiple sclerosis patients in treatment with fampridine

Treatment:

Behavioral: cognitive and behavioural questionnaires