Clinical trial NCT02966808: Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
Official title: Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with multiple sclerosis elegible for fampridine treatment according to drug lable.

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.

Eligibility criteria: Inclusion Criteria:

* patients with multiple sclerosis with fampridine treatment

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in speed of processing
timeFrame: 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: change in attention
timeFrame: 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: change in walking ability
timeFrame: 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: change in perception of walking ability
timeFrame: 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.
Secondary outcomes:
measure: change in fatigue
timeFrame: 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: change in quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Neurologist
name: Maria Luisa Martínez-Ginés, MD
role: PRINCIPAL_INVESTIGATOR
References: