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Safety and Efficacy of Fingolimod in MS Patients in China

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Novartis

Status and phase

Withdrawn
Phase 3

Conditions

Multiple Sclerosis (Relapsing Remitting)

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01941004
CFTY720D2315

Details and patient eligibility

About

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

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

-Patients must have relapsing remitting multiple sclerosis

Exclusion criteria

Patients with:

  • History of chronic immune disease
  • Certain cancers
  • Uncontrolled diabetes
  • Certain eye disorders -Negative for varicella
  • zoster virus IgG antibodies
  • Certain hepatic conditions
  • Low white blood cell count
  • On certain immunosuppressive medications or heart medications
  • Certain heart conditions or certain lung conditions
  • Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
  • Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

double blinded Fingolimod 6 mos + open label fingolimod 6 mos
Experimental group
Description:
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
Treatment:
Drug: fingolimod
Placebo 6 mos + open label fingolimod 6 mos
Placebo Comparator group
Description:
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
Treatment:
Drug: Placebo (6mos) + open label fingolimod (6 mos)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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