Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms (Cognition)

Novartis

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon beta 1b; Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333501

CFTY720DIT01

2010-023023-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Fingolimod

Experimental group

Description:

0.5 mg in capsules for oral administration once daily

Treatment:

Drug: Fingolimod

Interferon beta 1b

Active Comparator group

Description:

250 μg injected s.c. every other day

Treatment:

Drug: Interferon beta 1b