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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fampridine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognition measured with PASAT scale | Correlated with the multidimensional Health Related Quality of Life in MS patients | Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0). |
| Changes in depression measured with BDI-II scale | Correlated with the multidimensional Health Related Quality of Life in MS patients | Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0). |
| Changes in fatigue measured with MFIS scale | Correlated with the multidimensional Health Related Quality of Life in MS patients | Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0). |
| Changes in Quality of Life measured with MusiQoL scale | Correlated with the multidimensional Health Related Quality of Life in MS patients | Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0) |
| Changes in Quality of Life measured with MSIS-29 scale | Correlated with the multidimensional Health Related Quality of Life in MS patients | Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0) |
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Inclusion Criteria:
Exclusion Criteria:
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The target population of the current clinical study is male and female patients with MS, aged ≥18 years, receiving Fampyra for walking disability according to standard clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Αiginitio hospital | Athens | Attica | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33528792 | Derived | Mitsikostas DD, Doskas T, Gkatzonis S, Fakas N, Maltezou M, Papadopoulos D, Gourgioti R, Mitsias P. A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study. Adv Ther. 2021 Mar;38(3):1536-1551. doi: 10.1007/s12325-020-01606-5. Epub 2021 Feb 2. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |