NCT03164018

Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Genesis Pharma CNS & Specialty · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fampyra, a voltage-dependent potassium channel blocker, is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7). The medicinal product has been authorized under a so-called "conditional approval" scheme. This means that further evidence on this medicinal product is awaited and this study aims to assess the effect of Fampyra, administered according to standard clinical practice, on cognition, fatigue and quality of life in patients with MS. This clinical study is a multicenter, prospective, non-interventional, cohort study of MS patients receiving Fampyra in outpatient setting. Patients will be treated according to the local prescribing information of the study medication and routine medical practice in terms of visit frequency and types of assessments performed. The assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of Fampyra is clearly separated from the physician's decision to include the patient in the current study. Since this is purely non-interventional study, primary data -which will be obtained prospectively during the study visits through patients' interview and patient reported outcomes or as performed per standard clinical practice- will mainly be employed.

Detailed description

The study will take place in Greece. Investigator's decision to prescribe Fampyra (according to the indication for treatment as defined in the summary of product characteristics, SmPC and the current clinical practice), should precede entry into the study.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fampridine	The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments and management of the disease will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behavior.

Timeline

• Start date: 2017-03-07
• Primary completion: 2018-12-15
• Completion: 2018-12-15
• First posted: 2017-05-23
• Last updated: 2019-02-15

Locations

1 site across 1 country: Greece