Phase 4
Completed N=157
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
Source: ClinicalTrials.gov NCT01333501 ↗Enrolled (actual)
157
Serious AEs
6.6%
Results posted
Mar 2017
Primary outcomePrimary: Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score — 6.32; 4.46 raw score — p=0.4940
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score |
6.32; 4.46 | 0.4940 |
| PRIMARY Change From Screening in Selective Reminding Test - Consistent Long Term Retrieval (SRT-CLTR) Raw Score |
5.93; 3.96 | 0.5183 |
| PRIMARY Change From Screening in Spatial Recall Test (SPART) Raw Score |
1.46; 3.06 | 0.1334 |
| PRIMARY Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score |
2.19; 3.93 | 0.4501 |
| PRIMARY Change From Screening in Paced Auditory Serial Addition Test - 3 Seconds (PASAT 3) Raw Score |
7.14; 6.68 | 0.8561 |
| PRIMARY Change From Screening in Paced Auditory Serial Addition Test - 2 (PASAT 2) Raw Score |
4.79; 4.42 | 0.8858 |
| PRIMARY Change From Screening in Selective Reminding Test - Delayed Recall (SRT-D) Raw Score |
0.57; 0.39 | 0.7119 |
| PRIMARY Change From Screening in Spatial Recall Test - Delayed Recall (SPART-D) |
0.41; 0.44 | 0.9496 |
| PRIMARY Change From Screening in Word List Generation (WLG) |
0.39; 0.24 | 0.8944 |
| PRIMARY Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2 |
0.57; 0.82 | 0.6757 |
| PRIMARY Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2 |
1.52; 3.69 | 0.3585 |
| PRIMARY Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2 |
2.15; 7.38 | 0.1610 |
| SECONDARY Change From Screening in the Volume of Total T2 Lesions |
176.25; 711.81 | — |
| SECONDARY Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS) |
-0.77; 0.13 | — |
| SECONDARY Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54) |
4.76; -2.31; -1.80; -4.75 | — |
| SECONDARY Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains). |
2.36; 6.67 | — |
| SECONDARY Change From Screening in the Number of New T2 Lesions |
1.25; 3.33 | — |
| SECONDARY Change From Screening in the Volume of Total T1 Hypointense Lesions |
391.96; 213.93 | — |
| SECONDARY Change From Screening in the Number of T1 Gd+ Enhancing Lesions |
-0.64; 0.59 | — |
| SECONDARY Change From Screening in the Percentage of Brain Volume Change |
-0.60; -0.96 | — |
| SECONDARY Changes in the Environmental Status Scale Score (ESS) |
1.08; 0.91 | — |
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
Data sourced from ClinicalTrials.gov (NCT01333501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.