Trial record 1 of 2 for:    FTY 720 2306
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FTY720 in Patients With Primary Progressive Multiple Sclerosis (INFORMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00731692
First received: August 7, 2008
Last updated: May 21, 2014
Last verified: May 2014

August 7, 2008
May 21, 2014
July 2008
September 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To evaluate the effect of FTY720 relative to placebo on delaying the time to sustained disability progression
Complete list of historical versions of study NCT00731692 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of FTY720 compared to placebo in patients with PPMS
  • To evaluate the effect of FTY720 relative to placebo on conventional MRI parameters
  • To evaluate the effect of FTY720 relative to placebo on Patient Reported Outcomes
Not Provided
Not Provided
 
FTY720 in Patients With Primary Progressive Multiple Sclerosis
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

The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Progressive Multiple Sclerosis
  • Drug: FTY720
  • Drug: Placebo
    Capsules
  • Experimental: FTY720D 0.5 mg
    Intervention: Drug: FTY720
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: Downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
969
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

General

  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

Pulmonary:

  • 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

Hepatic:

  • 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

Other:

  • 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.

Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT00731692
CFTY720D2306, 2007-002627-32
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP