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

NCT03164018 | Completed

• 1 other identifier: NIS-GEN-FMP-001
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• 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)

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patient (≥18 years old) with MS.
• Patient receiving Fampyra® for walking disability (EDSS 4-7).
• Patient receiving stable doses of any Disease Modifying Treatment (DMT) for at least 3 months prior to study entry.
• Patients will receive Fampyra® in line with the approved Summary of Product Characteristics (SmPC).
• Patients for whom the decision to prescribe therapy with Fampyra according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study.
• Patients must have signed an informed consent document.
• Patients must be able to read, understand and complete the study specific questionnaires.

You may not qualify if:

• Pregnant or lactating woman.
• Patient with prior history or current presentation of seizure.
• Patient with mild, moderate or severe renal impairment (creatinine clearance \< 80 ml/min).
• Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
• Concomitant treatment with medicinal products that are inhibitors of Organic Transporter 2 (OCT2), e.g., cimetidine.
• Patients who have received more than 1 dose of fampridine at the time of enrollment into the study.
• Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC.
• Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with fampridine

Sponsors & Collaborators

• Genesis Pharma CNS & Specialty: lead

Study Sites (1)

Αiginitio hospital

Athens, Attica, 11528, Greece

Location

Related Publications (1)

• 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.

  PMID: 33528792 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: May 23, 2017
• Study Start: March 7, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

GR (1)