Clinical trial NCT01333501: Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
cognitive symptoms
relapsing-remitting multiple sclerosis (RRMS)
fingolimod
Magnetic resonance imaging (MRI)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Selective Reminding Test - Consistent Long Term Retrieval (SRT-CLTR) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Spatial Recall Test (SPART) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Paced Auditory Serial Addition Test - 3 Seconds (PASAT 3) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Paced Auditory Serial Addition Test - 2 (PASAT 2) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Selective Reminding Test - Delayed Recall (SRT-D) Raw Score
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Spatial Recall Test - Delayed Recall (SPART-D)
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Word List Generation (WLG)
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2
timeFrame: Screening (-1month), 18 month
Secondary outcomes:
measure: Change From Screening in the Volume of Total T2 Lesions
timeFrame: Screening (-1 month), 18 months
measure: Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Screening (-1month), 18 month
measure: Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54)
timeFrame: Baseline, 18 months
measure: Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains).
timeFrame: Baseline, 18 months
measure: Change From Screening in the Number of New T2 Lesions
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in the Volume of Total T1 Hypointense Lesions
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in the Number of T1 Gd+ Enhancing Lesions
timeFrame: Screening (-1month), 18 month
measure: Change From Screening in the Percentage of Brain Volume Change
timeFrame: Screening (-1month), 18 month
measure: Changes in the Environmental Status Scale Score (ESS)
timeFrame: Baseline, 18 month
Other outcomes:
Locations:
city: Alzenau
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Montichiari
country: Italy
facility: Novartis Investigative Site
state: BS
city: Chieti
country: Italy
facility: Novartis Investigative Site
state: CH
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Cefalù
country: Italy
facility: Novartis Investigative Site
state: PA
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Gallarate
country: Italy
facility: Novartis Investigative Site
state: VA
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: