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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 Prima

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Trial Conditions
  • Primary Progressive Multiple Sclerosis
What is the purpose of this trial?

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

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
25  - 65 

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Novartis Pharmaceuticals
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • Placebo
  • FTY720D 0.5 mg
  • capsule
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis
Phase: Phase 3
Trial ID: NCT00731692
Volunteers:  Not Accepting Healthy Volunteers

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