Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms (Cognition)
2017年1月30日 更新者：Novartis Pharmaceuticals
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
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.
研究概览
研究类型
介入性
注册 (实际的)
151
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alzenau、德国、63755
- Novartis Investigative Site
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Bamberg、德国、96049
- Novartis Investigative Site
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Leipzig、德国、04103
- Novartis Investigative Site
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Würzburg、德国、97080
- Novartis Investigative Site
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Napoli、意大利、80131
- Novartis Investigative Site
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Napoli、意大利、80138
- Novartis Investigative Site
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AN
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Ancona、AN、意大利、60126
- Novartis Investigative Site
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BA
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Bari、BA、意大利、70124
- Novartis Investigative Site
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BG
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Bergamo、BG、意大利、24128
- Novartis Investigative Site
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BS
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Montichiari、BS、意大利、25018
- Novartis Investigative Site
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CH
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Chieti、CH、意大利、66100
- Novartis Investigative Site
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CT
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Catania、CT、意大利、95123
- Novartis Investigative Site
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Catania、CT、意大利、95122
- Novartis Investigative Site
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FI
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Firenze、FI、意大利、50134
- Novartis Investigative Site
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GE
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Genova、GE、意大利、16132
- Novartis Investigative Site
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IS
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Pozzilli、IS、意大利、86077
- Novartis Investigative Site
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ME
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Messina、ME、意大利、98121
- Novartis Investigative Site
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MI
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Milano、MI、意大利、20132
- Novartis Investigative Site
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Milano、MI、意大利、20122
- Novartis Investigative Site
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PA
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Cefalù、PA、意大利、90015
- Novartis Investigative Site
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PV
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Pavia、PV、意大利、27100
- Novartis Investigative Site
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RM
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Roma、RM、意大利、00161
- Novartis Investigative Site
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Roma、RM、意大利、00133
- Novartis Investigative Site
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Roma、RM、意大利、00189
- Novartis Investigative Site
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Roma、RM、意大利、00179
- Novartis Investigative Site
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VA
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Gallarate、VA、意大利、21013
- Novartis Investigative Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Fingolimod
0.5 mg in capsules for oral administration once daily
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0.5 mg in capsules for oral administration once daily
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有源比较器：Interferon beta 1b
250 μg injected s.c.
every other day
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250 μg injected s.c.
every other day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score
大体时间：Screening (-1month), 18 month
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Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity.
It consists of the serial administration of 5 tests.
One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall).
A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials.
The total of the words in LTS of all six trials is then summed.
The total score ranged from 0 to 72.
Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Selective Reminding Test - Consistent Long Term Retrieval (SRT-CLTR) Raw Score
大体时间：Screening (-1month), 18 month
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Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity.
It consists of the serial administration of 5 tests.
One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall).
A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials.
The total of the words in LTS of all six trials is then summed.
If a word in LTS is consistently recalled on all subsequent trials, it is then scored as Consistent Long Term Retrieval (CLTR).
The total of the words in CLTR of all six trials is summed.
The total score ranged from 0 to 72.
Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Spatial Recall Test (SPART) Raw Score
大体时间：Screening (-1month), 18 month
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Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D).
A checkerboard with ten checkers arranged in a pattern is shown to the subject for ten seconds.
The subject is then asked to reproduce the same pattern with ten checkers on an empty checkerboard.
The test includes three consecutive trials.
The score is the total number of correct responses for the tree trials.
The total score ranged from 0 to 30.
Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score
大体时间：Screening (-1month), 18 month
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Symbol Digit Modality Test (SDMT) for sustained attention and information processing speed.
It presents a series of nine symbols, each of which is paired with a single digit labeled 1-9 in a key at the top of the sheet.
The reminder of the page has a pseudo-randomized sequence of symbols, and the patient must respond with the digit associated with each of these as quickly as possible.
The score is the number of correct answers in 90 seconds.
The total score ranged from 0 to 110.
Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Paced Auditory Serial Addition Test - 3 Seconds (PASAT 3) Raw Score
大体时间：Screening (-1month), 18 month
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Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed).
The patient hears a series of numbers from recordings that are presented at the rate of one every 3 seconds in the first part of the test (PASAT-3).
The patient is asked to add each consecutive digit to the one immediately preceding it.
Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers.
The total score ranged from 0 to 60. Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Paced Auditory Serial Addition Test - 2 (PASAT 2) Raw Score
大体时间：Screening (-1month), 18 month
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Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed).
The patient hears a series of numbers from recordings that are presented at the rate of one every 2 seconds in the second part of the test (PASAT-2).
The patient was asked to add each consecutive digit to the one immediately preceding it.
Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers.
The total score ranged from 0 to 60. Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Selective Reminding Test - Delayed Recall (SRT-D) Raw Score
大体时间：Screening (-1month), 18 month
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The tests SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall).
The Delayed SRT test is the total number of words recalled after a delayed period.
The total score ranged from 0 to 12. Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Spatial Recall Test - Delayed Recall (SPART-D)
大体时间：Screening (-1month), 18 month
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Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D).
A checkerboard with ten checkers arranged in a pattern was shown to the subject for ten seconds.
The subject was then asked to reproduce the same pattern with ten checkers on an empty checkerboard.
The test includes three consecutive trials.
The score was the total number of correct responses for the tree trials.
The total score ranged from 0 to 10. Higher values represent a better outcome.
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Screening (-1month), 18 month
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Change From Screening in Word List Generation (WLG)
大体时间：Screening (-1month), 18 month
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Word List Generation (COWAT/WLG): The COWAT assesses verbal fluency on semantic stimulus by asking the patient to produce as many words as possible belonging to a semantic category.
The test assessed the verbal fluency, recorded all the possible correct word that a patients should give in 90 sec.
No maximum range is available.
Higher values represent a better outcome.
The score was the number of correct words.
The more words the patient pronounces, the better it is.
We can imagine that the minimum value might be zero words, , but it is not a score scale.
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Screening (-1month), 18 month
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Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2
大体时间：Screening (-1month), 18 month
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The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities.
It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit).
The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. The DKFES test consisted of two testing procedures: free sorting and sort recognition.
In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts.
In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets.
The total score ranged from 0 to 16.
Higher values represent a better outcome
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Screening (-1month), 18 month
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Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2
大体时间：Screening (-1month), 18 month
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The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities.
It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit).
The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores.
In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets.
The total score ranged from 0 to 64.
Higher values represent a better outcome
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Screening (-1month), 18 month
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Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2
大体时间：Screening (-1month), 18 month
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The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities.
It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit).
The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. Free sorting and sort recognition.
In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores.
The total score ranged from 0 to 64.
Higher values represent a better outcome.
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Screening (-1month), 18 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Screening in the Volume of Total T2 Lesions
大体时间：Screening (-1 month), 18 months
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Change in volume of total T2-weighted lesions by visit were summarized.
Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume
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Screening (-1 month), 18 months
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Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS)
大体时间：Screening (-1month), 18 month
|
MADRS measures the overall severity of depressive symptoms.
The MADRS had a 10-item checklist.
Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
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Screening (-1month), 18 month
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Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54)
大体时间：Baseline, 18 months
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A 54 question measure covers 12 domains; assesses mental and physical health.
The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy.
The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.
Each domain has a range from 0 to 100 where higher means better.
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Baseline, 18 months
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Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains).
大体时间：Baseline, 18 months
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Modified Fatigue Impact Scale (mFIS) questionnaire is described at each time point to evaluate fatigue by means of usual descriptive statistics.
Three domains were also defined: Physical Subscale (sum of items 4, 6, 7, 10, 13, 14, 17, 20, 21 and therefore ranging from 0 to 36), Cognitive Subscale (sum of items 1, 2, 3, 5, 11, 12, 15, 16, 18, 19 and therefore ranging from 0 to 40) and Psychosocial Subscale (sum of items 8, 9 and therefore ranging from 0 to 8).
Finally, mFIS - overall score ranged from 0 to 80.
The mFIS total score was computed as the sum of scores for each item.
Lower values represent a better outcome.
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Baseline, 18 months
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Change From Screening in the Number of New T2 Lesions
大体时间：Screening (-1month), 18 month
|
New T2 lesions at a specific visit were assessed relative to the previous visit scan.
The total number of lesions (visit 8 to 18 month) is calculated as the sum of the number of lesions.
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Screening (-1month), 18 month
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Change From Screening in the Volume of Total T1 Hypointense Lesions
大体时间：Screening (-1month), 18 month
|
Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan.
Means were estimated using a Mixed-effect model with repeated measures (MMRM) by-visit interaction.
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Screening (-1month), 18 month
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Change From Screening in the Number of T1 Gd+ Enhancing Lesions
大体时间：Screening (-1month), 18 month
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Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit.
Real (not per slice) lesions are counted in this analysis
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Screening (-1month), 18 month
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Change From Screening in the Percentage of Brain Volume Change
大体时间：Screening (-1month), 18 month
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Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library.
SIENA is a fully automated method for estimating temporal brain volume change.
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Screening (-1month), 18 month
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Changes in the Environmental Status Scale Score (ESS)
大体时间：Baseline, 18 month
|
The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap.
It was derived from a measure of socio-economic status.
It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity.
Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35.
The higher the score the greater the handicap
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Baseline, 18 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2011年4月8日
首先提交符合 QC 标准的
2011年4月11日
首次发布 (估计)
2011年4月12日
研究记录更新
最后更新发布 (实际的)
2017年3月21日
上次提交的符合 QC 标准的更新
2017年1月30日
最后验证
2017年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CFTY720DIT01
- 2010-023023-19 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.