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

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: cognitive and behavioural questionnaires

• Registration Number: NCT02966808
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Study Start: 2016-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients with multiple sclerosis with fampridine treatment

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical measures	cognitive and behavioural questionnaires	multiple sclerosis patients in treatment with fampridine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain