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

Multiple Sclerosis Clinical Trial

— RETROFAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02966808
• Other study ID #: RETROFAM
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Yolanda Higueras, PhD
• Email: yolanda.higueras[@]iisgm.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with multiple sclerosis with fampridine treatment

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• cognitive and behavioural questionnaires

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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.
Secondary	change in quality of life	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.