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Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

NCT02219932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2017-03-27

Study results available
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Summary

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on participant-reported walking ability over a 24-week study period.

The secondary objectives are: to determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of multiple sclerosis (MS), and upper extremity function over a 24-week study period; to evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

Conditions

Interventions

DRUG

fampridine

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Bulgaria
  • Czechia
  • Finland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219932 on ClinicalTrials.gov