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

February 9, 2021 updated by: María Luisa Martinez Gines, Hospital General Universitario Gregorio Marañon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with multiple sclerosis elegible for fampridine treatment according to drug lable.

Description

Inclusion Criteria:

  • patients with multiple sclerosis with fampridine treatment

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical measures
multiple sclerosis patients in treatment with fampridine
Behavioral: cognitive and behavioural questionnaires
Other Names:
  • PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in speed of processing
Time Frame: 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 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.
change in attention
Time Frame: 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 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.
change in walking ability
Time Frame: 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 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.
change in perception of walking ability
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in fatigue
Time Frame: 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 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.
change in quality of life
Time Frame: 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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Maria Luisa Martínez-Ginés, MD, Neurologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETROFAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe