Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

Multiple Sclerosis Clinical Trial

— Cognition  

Official title:

A 18-month, Open-label, Rater-blinded, Randomized, Multi-center, Active-controlled, Parallel-group Pilot Study to Assess Efficacy and Safety of Fingolimod in Comparison to Interferon Beta 1b in Treating the Cognitive Symptoms Associated to Relapsing-remitting Multiple Sclerosis and to Assess Possible Relationship of These Effects to Regional Brain Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333501
• Other study ID #: CFTY720DIT01
• Secondary ID: 2010-023023-19
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2011
• Last updated: October 12, 2015
• Start date: May 2011
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: Agenzia italiana del farmaco (AIFA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate which test of the battery is the most sensitive in detecting differences between treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with relapsing-remitting forms of MS defined by 2005 revised McDonald criteria.

• Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months.

• Patients with cognitive impairment at screening, defined as at least one test of the Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the normative data.

Exclusion Criteria:

• Patients who had already been treated with multiweekly interferon (interferon beta 1b, or beta 1a multiweekly) and had an unsatisfactory response according to the judgment of the investigator.

• Patients with hyperactive forms of the MS disease according to the judgment of the investigator.

• Patients with an EDSS score higher than 5.

• Patients with a prior or current diagnosis of Major Depression according to DSM-IV.

• Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Neurobehavioral Manifestations
• Sclerosis

Intervention

Drug:
• Fingolimod

• Interferon beta 1b

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Alzenau
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Würzburg
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Cefalù	PA
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Gallarate	VA
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Messina	ME
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Montichiari	BS
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Pozzilli	IS
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate, by means of a specific cognitive test battery, the slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of treatment vs IFN ß1b, and to evaluate which test of the battery is the most sensitive.		18 months	No
Secondary	To evaluate how the effects on cognitive dysfunction progression are associated to the effect of slowing the brain volume reduction at MRI (antiatrophic effect) that DMDs might have in RRMS patients, in the brain as a whole and in specific brain regions.		18 months	No
Secondary	Evaluate in a subgroup of patients if and to what extent optical nerve atrophy as assessed by RNFL thickness is predictive of the atrophy of the relevant brain regions and of cognitive deterioration and to what extent this is affected by DMD treatment.		18 months	No
Secondary	To evaluate if fingolimod has effects on depression in MS and how the effects of fingolimod and interferon beta 1b on brain atrophy, on cognitive dysfunction progression and on depression in MS are associated.		18 months	No
Secondary	To evaluate changes in quality of life, by mean of the MSQoL54 scale, upon initiation of treatment with fingolimod 0.5 mg.		18 months	No
Secondary	To evaluate changes in fatigue (mFIS, total score and scores of the 3 individual domains).		18 months	No