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Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

NCT01625182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2017-10-30

Study results available
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Summary

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

DRUG

Fingolimod

Fingolimod 0.5 mg capsules

DRUG

Placebo Comparator

Matching placebo capsules

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-22
Primary Completion
2016-09-03
Completion
2016-09-03
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01625182 on ClinicalTrials.gov