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FTY720 in Patients With Primary Progressive Multiple Sclerosis (INFORMS)

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: August 7, 2008
Last updated: April 13, 2015
Last verified: April 2015
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS.

Condition Intervention Phase
Primary Progressive Multiple Sclerosis
Drug: FTY720
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To evaluate the effect of FTY720 relative to placebo on delaying the time to sustained disability progression for patients treated for at least 36 months [ Time Frame: When the last still ongoing patient in the double-blind treatment phase completes Month 36 of the study ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of FTY720 compared to placebo in patients with PPMS [ Time Frame: when the last patient still ongoing in the study completes Month 36 of the double blind treatment phase ]
  • To evaluate the effect of FTY720 relative to placebo on conventional MRI parameters [ Time Frame: When the last still ongoing patient in the double-blind treatment phase completes Month 36 of the study ]
  • To evaluate the effect of FTY720 relative to placebo on Patient Reported Outcomes [ Time Frame: When the last still ongoing patient in the double-blind treatment phase completes Month 36 of the study ]

Enrollment: 969
Study Start Date: July 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTY720D 0.5 mg Drug: FTY720
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  1. sign written informed consent prior to participating in the study
  2. 25 through 65 years of age inclusive
  3. females of childbearing potential must:

    • have a negative pregnancy test at Baseline (prior to randomization) and
    • use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication

Primary Progressive Multiple sclerosis.

  1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
  2. time since first reported symptoms between 2 and 10 years
  3. evidence of clinical disability progression in the 2 years prior to Screening
  4. disability status at Screening

    • EDSS score of 3.5-6.0 inclusive
    • pyramidal functional system score of 2 or more
    • 25'TWT less than 30 seconds

Exclusion Criteria:

PPMS specific:

  • History of relapses/attacks
  • Progressive neurological disorder other than PPMS
  • Pure cerebellar syndrome or pure visual progressive syndrome or pure
  • cognitive progressive syndrome
  • Presence of spinal cord compression at screening MRI
  • Relevant history of vitamin B12 deficit
  • Evidence of syphilis or borreliosis at Screening

Cardiovascular conditions:

  • Myocardial infarction within the past 6 months or current unstable ischemic heart disease
  • History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
  • Severe cardiac failure or cardiac arrest
  • History of symptomatic bradycardia
  • Resting pulse <55 bpm pre-dose
  • History of sick sinus syndrome or sino-atrial heart block
  • History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms)
  • Arrythmia requiring treatment with class III antiarrythmic drugs
  • History of positive tilt test from workout of vasovagal syncope
  • Hypertension, not controlled with medication


  • Severe respiratory disease or pulmonary fibrosis
  • TB
  • Abnormal X-ray, suggestive of active pulmonary disease
  • Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO
  • Patients receiving chronic (daily) therapies for asthma


  • Known history of alcohol abuse, chronic liver or biliary disease
  • Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome
  • AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN


  • History of chronic disease of the immune system other than MS
  • Malignancy (other than successfully treated SCC or BCC)
  • Diabetes Mellitus
  • Macular Edema present at screening
  • HIV, Hepatitis C or B, other active infection
  • History of total lymphoid irradiation or bone marrow transplantation
  • Serum creatinine >1.7 mg/dl
  • WBC <3500 cells/mm3
  • Lymphocyte count <800 cells/mm3
  • History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
  • Unable to undergo MRI scans
  • Participation in any therapeutical clinical research study in the 6 months prior to randomization
  • Pregnant or lactating women
  • Drugs requiring wash-out period:

    3 months:

    • Systemic corticosteroids or ACTH
    • INF-beta

      6 months:

    • Immunosuppressive medication
    • Immunoglobulins
    • Monoclonal antibodies
  • Drugs that exclude participation in the study:
  • Cladribine
  • Cyclophosphamide
  • Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00731692

  Show 158 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00731692     History of Changes
Obsolete Identifiers: NCT01779934
Other Study ID Numbers: CFTY720D2306
2007-002627-32 ( EudraCT Number )
Study First Received: August 7, 2008
Last Updated: April 13, 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
FTY720, primary progressive multiple sclerosis,PPMS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017