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

Multiple Sclerosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164018
• Other study ID #: NIS-GEN-FMP-001
• Status: Completed
• Start date: March 7, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: February 2019
• Source: Genesis Pharma CNS & Specialty
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Fatigue
• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Greece	?iginitio hospital	Athens	Attika

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Pharma CNS & Specialty

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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)
Primary	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)