Clinical trial NCT03164018: Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
Official title: Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Genesis Pharma CNS & Specialty
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in cognition measured with PASAT scale
timeFrame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
measure: Changes in depression measured with BDI-II scale
timeFrame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
measure: Changes in fatigue measured with MFIS scale
timeFrame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0).
measure: Changes in Quality of Life measured with MusiQoL scale
timeFrame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
measure: Changes in Quality of Life measured with MSIS-29 scale
timeFrame: Assessed at 2 weeks, 12 weeks and 24 weeks compared to Baseline (week 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Αiginitio hospital
state: Attika
Study officials:
References:
citation: 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.