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

Primary Progressive Multiple Sclerosis Clinical Trial

— FTY720  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779934
• Other study ID #: CFTY720D2306E1
• Secondary ID: 2012-000835-18
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2012
• Last updated: February 16, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Primary Progressive Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• FTY720
Open-label 0.5 mg FTY720 administered orally in patients with primary progressive multiple sclerosis

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Parkville	Victoria
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Melsbroek
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Gatineau	Quebec
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Czech Republic	Novartis Investigative Site	Brno
Czech Republic	Novartis Investigative Site	Ostrava-Poruba
Czech Republic	Novartis Investigative Site	Plzen
Czech Republic	Novartis Investigative Site	Praha 2
Czech Republic	Novartis Investigative Site	Teplice
Denmark	Novartis Investigative Site	Aarhus
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Tampere
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Marseille cedex 05
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Paris Cedex 13
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	Strasbourg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hennigsdorf
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Teupitz
Germany	Novartis Investigative Site	Würzburg
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor
Hungary	Novartis Investigative Site	Veszprem
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Cefalù	PA
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Gallarate	VA
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Montichiari	BS
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Breda
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Nieuwegein
Netherlands	Novartis Investigative Site	Sittard-Geleen
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Lublin
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Girona	Catalunya
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Lugano
Switzerland	Novartis Investigative Site	Zuerich
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Atakum / Samsun
Turkey	Novartis Investigative Site	Balcova / Izmir
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Yenisehir / Izmir
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London	South Yorkshire
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Sheffield
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Burlington	Vermont
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Charlottesville	Virginia
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pompano Beach	Florida
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Stony Brook	New York
United States	Novartis Investigative Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Disease activity measured by Kurtzke's Expanded Disability Status Scale (EDSS)	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.	Baseline, 24 months	No
Primary	Change from baseline inDisease activity measured by 9-Hole Peg Test (9HPT)	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	baseline, 24 months	No
Primary	Change in Disease activity measured by 25 ft Timed Walk Test (25'TWT)	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.	baseline, 24 months	No
Primary	Change in Disease Activity measured by Magnetic Resonance Imaging (MRI) parameters	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.	baseline, 24months	No
Secondary	Number of patients with AE/SAE as assessment of safety and tolerability	Analysis will report overall AE/SAE and death.	Baseline to 24 months	Yes