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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497262
• Other study ID #: CFTY720D2325
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2011
• Last updated: March 17, 2015
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ministry of HealthArgentina: Ministry of HealthColombia: Institutional Review BoardJordan: Ethical CommitteeMalaysia: Ministry of HealthMexico: Ministry of HealthPanama: Ministry of HealthPeru: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Fingolimod
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Guaymallen	Mendoza
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucumán
Argentina	Novartis Investigative Site	San Miguel de Tucumán	Tucumán
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Cali
Jordan	Novartis Investigative Site	Amman
Jordan	Novartis Investigative Site	Irbid
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Penang
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	México	Distrito Federal
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	San Luis Potosí
Mexico	Novartis Investigative Site	San Nicolas De Los Garza	Nuevo León
Panama	Novartis Investigative Site	Panama City	Panamá
Peru	Novartis Investigative Site	Jesus Maria	Lima
Peru	Novartis Investigative Site	La Perla	Callao
Peru	Novartis Investigative Site	San Isidro	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Jordan,  Malaysia,  Mexico,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity	28 weeks	Yes
Secondary	Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.	The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.	4 months	Yes