218MS305-Fampridine in Subjects with Multiple Sclerosis (ENHANCE)
Research type
Research Study
Full title
A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE).
IRAS ID
155144
Contact name
Jeremy Hobart
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2013-003600-40
Research summary
This is a multicentre, randomised, placebo-controlled phase 3 study with a 24-week double-blind treatment period. Approximately 590 subjects with primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting Multiple Sclerosis ("MS") are planned to be randomised. Approximately 102 sites worldwide will participate in this study.
The main purpose of this research study is to see if fampridine has a clinically meaningful effect on patient-reported walking ability. Blood and urine samples will be obtained to assess the safety profile of fampridine. There will also be an optional DNA testing, which will explore identification of specific genetic markers associated with response to study treatment.
Subjects will be screened up to 14 days prior to Day 1. Eligible subjects will be enrolled into the study, and after undergoing baseline assessments, will be randomised to receive fampridine or placebo, in a 1:1 fashion. The study drug will be taken orally, twice a day, for 24 weeks. The duration of subject participation in this study will be approximately 28 weeks, which will include a 14-day screening period, a 24-week randomized study treatment period, and a 14 (±3) day postdosing follow-up.
The slow-release fampridine has been approved in the United States as a treatment to improve walking in patients with MS (demonstrated by an increase in walking speed) under the name Ampyra. Fampridine has also been approved under the brand name Fampyra in the European Union and other countries.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
14/SW/1029
Date of REC Opinion
15 Sep 2014
REC opinion
Further Information Favourable Opinion