Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01333501
• Date of registration: 08/04/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms Cognition
• Scientific 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
• Date of first enrolment: May 2011
• Target sample size: 151
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01333501
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Germany, Italy

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon beta 1b

Drug: Fingolimod

Primary Outcome(s)

Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2 [Time Frame: Screening (-1month), 18 month]

Change From Screening in Paced Auditory Serial Addition Test - 3 Seconds (PASAT 3) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Paced Auditory Serial Addition Test - 2 (PASAT 2) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Spatial Recall Test (SPART) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Spatial Recall Test - Delayed Recall (SPART-D) [Time Frame: Screening (-1month), 18 month]

Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2 [Time Frame: Screening (-1month), 18 month]

Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2 [Time Frame: Screening (-1month), 18 month]

Change From Screening in Selective Reminding Test - Consistent Long Term Retrieval (SRT-CLTR) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Word List Generation (WLG) [Time Frame: Screening (-1month), 18 month]

Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score [Time Frame: Screening (-1month), 18 month]

Change From Screening in Selective Reminding Test - Delayed Recall (SRT-D) Raw Score [Time Frame: Screening (-1month), 18 month]

Secondary Outcome(s)

Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS) [Time Frame: Screening (-1month), 18 month]

Change From Screening in the Volume of Total T1 Hypointense Lesions [Time Frame: Screening (-1month), 18 month]

Change From Screening in the Number of New T2 Lesions [Time Frame: Screening (-1month), 18 month]

Change From Screening in the Number of T1 Gd+ Enhancing Lesions [Time Frame: Screening (-1month), 18 month]

Change From Screening in the Volume of Total T2 Lesions [Time Frame: Screening (-1 month), 18 months]

Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains). [Time Frame: Baseline, 18 months]

Change From Screening in the Percentage of Brain Volume Change [Time Frame: Screening (-1month), 18 month]

Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54) [Time Frame: Baseline, 18 months]

Changes in the Environmental Status Scale Score (ESS) [Time Frame: Baseline, 18 month]

Secondary ID(s)

2010-023023-19

CFTY720DIT01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01333501