Status:
TERMINATED
Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the...
Eligibility Criteria
Inclusion
- Written informed consent to participate in the trial
- Males and females between 18 and 55 years of age;
- Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
- MS-subtype: Clinical isolated syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Secondary progressive Multiple Sclerosis (SPMS);
- Cognitive Impairment
- Sufficient education to read, write and communicate comprehensibly
Exclusion
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception
- With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements
- 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).
- Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.
- With a history or current problem of drug-addiction and/or alcohol abuse.
- 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)
- With a history of severe or moderate-severe cranioencephalic trauma.
- 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.
- With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).
- Severe depressive symptoms indicated by a score of more than ≥ 14 on the MADRS at screening
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00881205
Start Date
April 1 2009
End Date
January 1 2011
Last Update
March 12 2012
Active Locations (49)
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1
Novartis Investigative Site
Aachen, Germany, 52062
2
Novartis Investigative Site
Aalen, Germany, 73430
3
Novartis Investigative Site
Abensberg, Germany, 93326
4
Novartis Investigative Site
Achim, Germany, 28832