Know Cancer

or
forgot password

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


Phase 3
25 Years
65 Years
Open (Enrolling)
Both
Primary Progressive Multiple Sclerosis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Outcome Time Frame:

When the last still ongoing patient in the double-blind treatment phase completes Month 36 of the study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CFTY720D2306

NCT ID:

NCT00731692

Start Date:

July 2008

Completion Date:

September 2014

Related Keywords:

  • Primary Progressive Multiple Sclerosis
  • FTY720, primary progressive multiple sclerosis,PPMS
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Chronic Progressive

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Mount Sinai School of MedicineNew York, New York  10029
Fletcher Allen Health CareBurlington, Vermont  05401
Northwestern Memorial HospitalChicago, Illinois  60611
University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Rochester Medical CenterRochester, New York  14642
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Brigham and Women's HospitalBoston, Massachusetts  02115
University of PittsburghPittsburgh, Pennsylvania  15261
Duke UniversityDurham, North Carolina  27710
Vanderbilt UniversityNashville, Tennessee  37232-6305
University of Chicago Medical CenterChicago, Illinois  60637
Ohio State UniversityColumbus, Ohio  43210
University of MarylandBaltimore, Maryland  21201
University of Texas Southwestern Medical CenterDallas, Texas  
University of Colorado DenverDenver, Colorado  80262
Neurological AssociatesSunrise, Florida  33351
University of Virginia Health SystemCharlottesville, Virginia  22903
University of Texas Medical SchoolGalveston, Texas  77555-1083
Axiom Clinical Research of FloridaTampa, Florida  
Integra Clinical ResearchSan Antonio, Texas  
Multiple Sclerosis Center of Southern California & ResearchNewport, California  92660
University of California at Davis Health SystemSacramento, California  95817-2307
Associated Neurologists, P.C.Danbury, Connecticut  06810
The Multiple Sclerosis Center of AtlantaAtlanta, Georgia  30302
Johns Hopkins MS CenterBaltimore, Maryland  21287
Caritas St. Elizabeth HospitalBrighton, Massachusetts  02135
Wayne State University - University Health CenterDetroit, Michigan  48201
Washington University School of Medicine in St. LouisSt. Louis, Michigan  63110
Washington University School Of Medicine-Siteman Cancer CtrSt. Louis, Missouri  63110
MS Comprehensive Care Center at Holy Name HospitalTeaneck, New Jersey  07666
Kaleida Health Buffalo General HospitalBuffalo, New York  14203
SUNY - Stony Brook UniversityStony Brook, New York  11794-8121
Neuroscience and Spine InstituteCharlotte, North Carolina  28207
Sibyl Wray Neurology, PCKnoxville, Tennessee  37934
Seattle Neuro Institute at Swedish Med Ctr.Seattle, Washington  98122