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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01333501
First received: April 8, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Fingolimod
Drug: Interferon beta 1b
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 β1b, and to evaluate which test of the battery is the most sensitive. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To evaluate changes in quality of life, by mean of the MSQoL54 scale, upon initiation of treatment with fingolimod 0.5 mg. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To evaluate changes in fatigue (mFIS, total score and scores of the 3 individual domains). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod Drug: Fingolimod
Active Comparator: Interferon beta 1b Drug: Interferon beta 1b

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333501

Locations
Germany
Novartis Investigative Site
Alzenau, Germany, 63755
Novartis Investigative Site
Bamberg, Germany, 96049
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Würzburg, Germany, 97080
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Bari, BA, Italy, 70124
Novartis Investigative Site
Bergamo, BG, Italy, 24128
Novartis Investigative Site
Montichiari, BS, Italy, 25018
Novartis Investigative Site
Chieti, CH, Italy, 66100
Novartis Investigative Site
Catania, CT, Italy, 95122
Novartis Investigative Site
Catania, CT, Italy, 95123
Novartis Investigative Site
Firenze, FI, Italy, 50134
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Pozzilli, IS, Italy, 86077
Novartis Investigative Site
Messina, ME, Italy, 98121
Novartis Investigative Site
Milano, MI, Italy, 20132
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Cefalù, PA, Italy, 90015
Novartis Investigative Site
Fidenza, PR, Italy, 43036
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Roma, RM, Italy, 00179
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Roma, RM, Italy, 00189
Novartis Investigative Site
Roma, RM, Italy, 00133
Novartis Investigative Site
Gallarate, VA, Italy, 21013
Novartis Investigative Site
Napoli, Italy, 80138
Novartis Investigative Site
Napoli, Italy, 80131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01333501     History of Changes
Other Study ID Numbers: CFTY720DIT01, 2010-023023-19
Study First Received: April 8, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
Italy: Agenzia italiana del farmaco (AIFA)

Keywords provided by Novartis:
Multiple sclerosis
cognitive symptoms
relapsing-remitting multiple sclerosis (RRMS)
fingolimod
Magnetic resonance imaging (MRI)

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Neurobehavioral Manifestations
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
Neurologic Manifestations
Signs and Symptoms
Interferon-beta
Interferons
Interferon beta-1b
Fingolimod
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 14, 2014