Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

NCT ID: NCT00881205

Last Updated: 2012-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-01-31

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 Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.

Conditions

Multiple Sclerosis; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rivastigmine

Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.

Group Type: EXPERIMENTAL

Rivastigmine transdermal patch

Intervention Type: DRUG

Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color.

Placebo

Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and color of rivastigmine patches.

Interventions

Rivastigmine transdermal patch

Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color.

Intervention Type: DRUG

Placebo

Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and color of rivastigmine patches.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

4. MS-subtype: Clinical isolated syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Secondary progressive Multiple Sclerosis (SPMS);

5. Cognitive Impairment

6. Sufficient education to read, write and communicate comprehensibly

Exclusion Criteria

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. 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

3. With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements

4. 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).

5. Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.

6. With a history or current problem of drug-addiction and/or alcohol abuse.

7. 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)

8. With a history of severe or moderate-severe cranioencephalic trauma.

9. 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.

10. With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).

11. Severe depressive symptoms indicated by a score of more than ≥ 14 on the MADRS at screening

12. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Aachen, , Germany

Novartis Investigative Site

Aalen, , Germany

Novartis Investigative Site

Abensberg, , Germany

Novartis Investigative Site

Achim, , Germany

Novartis Investigative Site

Alzenau in Unterfranken, , Germany

Novartis Investigative Site

Aschaffenburg, , Germany

Novartis Investigative Site

Bad Mergentheim, , Germany

Novartis Investigative Site

Bayreuth, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative SIte

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bochum, , Germany

Novartis Investigative Site

Böblingen, , Germany

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Düsseldorf, , Germany

Novartis Investigative Site

Eisenach, , Germany

Novartis Investigative Site

Ellwangen, , Germany

Novartis Investigative Site

Erbach im Odenwald, , Germany

Novartis Investigative Site

Erlangen, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Giessen, , Germany

Novartis Investigative Site

Göttingen, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigational Site

Hamburg, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Itzehoe, , Germany

Novartis Investigative Site

Kaltenkirchen, , Germany

Novartis Investigative Site

Krefeld, , Germany

Novartis Investigative Site

Lappersdorf, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Ludwigshafen, , Germany

Novartis Investigative Site

Lüneburg, , Germany

Novartis Investigative Site

Neu-Ulm, , Germany

Novartis Investigative Site

Neuburg am Inn, , Germany

Novartis Investigative Site

Oldenburg, , Germany

Novartis Investigative Site

Osnabrück, , Germany

Novartis Investigative Site

Rostock, , Germany

Novartis Investigative Site

Stade, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Novartis Investigative Site

Stuttgart, , Germany

Novartis Investigative Site

Ulm, , Germany

Novartis Investigative Site

Unterhaching, , Germany

Novartis Investigative Site

Viernheim, , Germany

Novartis Investigative Site

Wiesbaden, , Germany

Novartis Investigative Site

Wolfratshausen, , Germany

Countries

Germany

Other Identifiers

CENA713DDE18

Identifier Type: -

Identifier Source: org_study_id