A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase
- Conditions
- cognitive impairment in Multiple SclerosisMedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
- Registration Number
- EUCTR2008-007015-32-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1)Written informed consent to participate in the trial
2)Males and females between 18 and 55 years of age;
3)Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 4)
4)MS-subtype: CIS, RRMS, SPMS;
6)Stable and well tolerated therapy with interferon beta-1b (Extavia®) for at least 60 days immediately prior to baseline. This period does not apply to patients swithed directly from Betaferon.
7)Cognitive Impairment defined as FST score of =3.0 and/or MUSIC score of =19 at screening
8)Verbal memory impairment defined as a score =0.5 standard deviations (SD) below age- and sex-based normative data on the RAVLT score at screening
9)Sufficient education to read, write and communicate comprehensibly
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2.Patient with advanced disease serious enough to, under the judgment of the physician-investigator, place the patient at a special risk situation.
3.Women
owho are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
owho are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception
4.With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements
5.Patients without contractual capability.
6.Patients suffering any other type of concomitant psychiatric and/or neurological disorder other than MS which is known to affect cognition (e.g. severe depressive symptoms, cerebrovascular diseases, epilepsy).
7.Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.
8.Patients on any other treatment for MS than described in inclusion criteria
9.With a history or current problem of drug-addiction and/or alcohol abuse.
10.Current or historical laboratory evidence of vitamin B1 and/or vitamin B12 deficit
11.Known or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting and =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
12.Any of the following hepatic conditions:
•total or conjugated bilirubin greater than 2 times the upper limit of the normal range, unless in context of Gilbert’s syndrome
•AST (=SGOT), ALT (=SGPT) greater than 3 times the upper limit of the normal range
13.With any of the following abnormal laboratory values at screening:
•serum creatinine >2 ULN or a history of hemodialysis
•white blood cell (WBC) count <3,500/mm³ (<3.5 x 109 / L)
•Serum electrolyte, BUN and Thyroidea stimulating hormone (TSH) concentrations outside the range as specified also in Appendix 2.
14.With a history of severe or moderate-severe cranioencephalic trauma.
15.Study personnel or first degree relatives of investigator(s) must not be included in the study
16.History or presence of any intolerance or contraindication for the application of rivastigmine (or for drugs with similar chemical structures) as listed in the current Investigator’s Brochure and/or SPC, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, convulsions.
17.Patients with any of the following diseases serious or unstable: gastrointestinal disease; clinically significant urinary obstruction under clinical judgement; acute, severe or unstable asthmatic conditions [for instance, severe chronic obstructive pulmonary disease (COPD)]; current and known diagnosis of severe or unstable cardiovascular disease; current and known diagnosis of bradycardia (? 40 bpm), sinus syndrome or conductivity disorders (atrial sinus blockage, 2nd or 3rd degree atrioventricular block).
18.With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).
19.Severe depressive symptoms indicated by a score of more than = 14 on the MADRS at screening
20.Patients who have performed a cognitive testing with Brief rep
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method