MedTrace Logo

Safety and Efficacy of Fingolimod in MS Patients in China

NCT01941004 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-04-21

No results posted yet for this study

Summary

To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

Conditions

  • Multiple Sclerosis (Relapsing Remitting)

Interventions

DRUG

fingolimod

Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

DRUG

Placebo (6mos) + open label fingolimod (6 mos)

Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-05-31
Completion
2017-05-31

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 NCT01941004 on ClinicalTrials.gov