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

Launched by GENESIS PHARMA CNS & SPECIALTY · May 22, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

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