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OL, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01779934
First received: October 26, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

To provide data on the long-term safety and tolerability of FTY720 in patients with primary progressive MS when administered via capsule once daily.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in Disease activity measured by Kurtzke's Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Kurtzke's Expanded Disability Status Scale (EDSS): assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above.

  • Change from baseline inDisease activity measured by 9-Hole Peg Test (9HPT) [ Time Frame: baseline, 24 months ] [ Designated as safety issue: No ]
    9-Hole Peg Test (9HPT): The time to 3-month confirmed disability progression based on the occurrence of any events as measured by ther 9-HPT

  • Change in Disease activity measured by 25 ft Timed Walk Test (25'TWT) [ Time Frame: baseline, 24 months ] [ Designated as safety issue: No ]
    25 ft Timed Walk Test (25'TWT): The time to 3-month confirmed disability progression based on the occurrence of any events as measured by the 25'TWT.

  • Change in Disease Activity measured by Magnetic Resonance Imaging (MRI) parameters [ Time Frame: baseline, 24months ] [ Designated as safety issue: No ]
    MRI: change/percent change from baseline in predefined MRI parameter including (but not limited to): total volume of T1-hypointense lesions, T2-weighted hyperintense lesion count, new/newly-enlarged T2 lesions and total volume of T2 lesions, changes in brain volume.


Secondary Outcome Measures:
  • Number of patients with AE/SAE as assessment of safety and tolerability [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: Yes ]
    Analysis will report overall AE/SAE and death.


Estimated Enrollment: 750
Study Start Date: January 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTY720
Patients will be assigned to open label single arm treatment with FTY720, 0.5 mg/d
 Drug: FTY720
Open-label 0.5 mg FTY720 administered orally in patients with primary progressive multiple sclerosis

  Eligibility

Ages Eligible for Study:   28 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (1) Patients who have provided written informed consent (2a) Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, who have completed at least 3 years on study drug treatment at the time of extension study initiation OR (2b) Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort who have continued on study drug treatment until such time as the last ongoing patient enrolled in the study has reached 3 years in study.

Exclusion Criteria:

  • Active chronic disease of the immune system other than MS or a known immunodeficiency syndrome,
  • Active systemic bacterial, viral or fungal infections,
  • Uncontrolled diabetes mellitus,
  • Positive lab markers for hepatitis A, B, C, and E indicating acute or chronic infection, * Macular edema at baseline
  • Treatment with Class Ia or III antiarrhythmic drugs, cardio-vascular conditions including Myocardial infarction, current unstable ischemic heart disease, cardiac failure or any severe cardiac disease, increased QTc (Fridericia and Bazett) interval >500 ms, Hypertension, uncontrolled by medication; Pulmonary conditions including severe respiratory disease or pulmonary fibrosis, active tuberculosis; Hepatic conditions including elevated Total or conjugated bilirubin, elevated consecutive alkaline phosphatase, AST (SGOT), ALT (SGPT) or gamma-glutamyl-transferase values greater; Any medically unstable condition, or participation in any clinical research study other than CFTY720D2306; pregnant or nursing (lactating) women - Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779934

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 122 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01779934     History of Changes
Other Study ID Numbers: CFTY720D2306E1, 2012-000835-18
Study First Received: October 26, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
PPMS
primary progressive multiple sclerosis
progressive MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013