Long Term Prolonged Release Fampridine Treatment and Quality of Life
Research type
Research Study
Full title
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis
IRAS ID
92262
Contact name
Carolyn Anne Young
Sponsor organisation
Biogen Idec Limited
Eudract number
2011-003507-38
Research summary
Long Term Prolonged Release Fampridine Treatment and Quality of Life The purpose of the study is to collect information on how long term use of prolonged release fampridine may affect quality of life and performance of daily activities as assessed by various self completed questionnaires. Another purpose of this study is to find out more about the safety and side effects of long term use of prolonged release fampridine (prolonged release means that the active ingredient in the tablet is released into your bloodstream throughout the day rather than all at once). Prolonged release fampridine is approved for improvement of walking in adult patients with multiple sclerosis (MS) with walking disability.Patients will come to the clinic for 8 scheduled visits over a 12 month period. Patients will take a 10 mg tablet of study medicine 2 times a day (every 12 hours) for at least 4 weeks. After 4 weeks of study medicine, your study doctor will then determine whether or not you have responded to treatment with prolonged release fampridine. Patients who have responded will continue to receive prolonged release fampridine for the next 44 weeks. Patients who have not responded will be offered the opportunity to continue study participation but will not receive any more prolonged release fampridine Approximately 800 patients will take part in this study at about 75 hospitals and clinics.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/NW/0822
Date of REC Opinion
6 Jan 2012
REC opinion
Further Information Favourable Opinion