CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Fampridine-SR +1 moredrug
Likely dose
Fampridine-SR 10 mg orally twice dailyAI-extracted
Key inclusion· 2
  • ✓Confirmed diagnosis of multiple sclerosis
  • ✓Able to walk with or without an assistive device
Key exclusion· 4
  • ✕Pregnancy or breastfeeding
  • ✕Females of childbearing potential not using adequate contraception
  • ✕Concurrent participation in other investigational drug trials
  • ✕Prior treatment with 4-aminopyridine (4-AP)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00127530
NCT00127530Phase 3Completed
CompareCT.gov

Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Acorda Therapeutics·interventional·Posted Aug 8, 2005·Updated Sep 11, 2018

In Brief

A Phase 3 clinical trial evaluating Fampridine-SR and Placebo for Multiple Sclerosis. Completed, enrolled 300 participants across 34 sites in 2 countries.

Detailed Summary

To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2005
Enrollment StartMay 1, 2005
Primary CompletionJun 1, 2006
Study CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.9 years ago

Interventions

Fampridine-SRdrug

Tablets, 10 mg, twice daily, 14 weeks

Placebodrug

sugar pill, twice a day (b.i.d.)