Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis - Full Text View

Purpose

This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod Fingolimod hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

The incidence rate of adverse events (AEs and SAEs) [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
The incidence of AEs (new or worsened from baseline) and suspected study drug related AEs or developed into an SAE after the start of the treatment will be summarized as the frequency count as well as the percentage of patients with AEs by primary system organ class (SOC), preferred term, severity and relationship to study drug.

In addition, the incidence of death, SAEs (including infections), AEs (including infections) leading to premature discontinuation of study drug, and other significant AEs will be summarized separately by primary system organ class and preferred term.

Secondary Outcome Measures:

Incidence of cardiovascular (bradyarrhythmias and blood pressure increase) events during the first dose administration [ Time Frame: 1,2,3,4,5 and 6 hours ] [ Designated as safety issue: Yes ]
Incidence of bradyarrhythmias will be assessed based on the AEs. Summary statistics for the incidence of bradyarrhythmias will be reported with the primary analyses.

Incidence of bradyarrhythmias will be assessed up to 6 hours post initial dose. Incidence of blood pressure increase will be assessed using data from the vital signs. The frequencies and percentages of patients with blood pressure increase will be summarized.
Incidence of liver transaminase elevations [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Incidence of liver transaminase elevations will be assessed using data from liver function tests. The frequencies and percentages of patients with elevations of 1, 2, 3, 5, and 10 times of the upper limit of normal will be summarized.
Incidence of infections [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Incidence of all infections will be assessed based on the AEs. Summary statistics for the incidence of infections will be reported within the primary analyses. Infections will be summarized separately by preferred term.
Percentage of patient developing macular edema during the study [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
The incidence of macular edema will be assessed using data from the ophthalmic assessments (including, but not limited to, best-corrected visual acuity, dilated ophthalmoscopy, fundus examination, FA and OCT), and will be summarized as frequency distributions.

Estimated Enrollment:	300
Study Start Date:	February 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fingolimod Open-label fingolimod 0.5 mg, taken orally once daily for 4 months	Drug: Fingolimod Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with relapsing remitting Multiple Sclerosis
Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

Exclusion Criteria:

Patients with MS other than relapsing remitting MS
Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
Patients who have been treated with:
- systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
- immunosuppressive medications within 3 months prior to baseline;
- monoclonal antibodies within 3 months prior to baseline;
- cladribine, mitoxantrone or alemtuzumab at any time.
Uncontrolled diabetes mellitus at screening
Diagnosis of macular edema during Screening Phase
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
Patients with certain cardiovascular conditions and/or findings in the screening ECG
Patients with certain liver conditions
Pregnant confirmed by a positive pregnancy test t 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: NCT01497262

Contacts

Contact: Novartis Pharmaceuticals	+41613241111
Contact: Novartis Pharmaceuticals

Show 43 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01497262 History of Changes
Other Study ID Numbers:	CFTY720D2325
Study First Received:	December 5, 2011
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration Brazil: Ministry of Health Argentina: Ministry of Health Colombia: Institutional Review Board Jordan: Ethical Committee Malaysia: Ministry of Health Mexico: Ministry of Health Panama: Ministry of Health Peru: Ministry of Health

Keywords provided by Novartis:

Multiple Sclerosis
Relapsing-Remitting

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 21, 2013