Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

Multiple Sclerosis Clinical Trial

— EXCITING  

Official title:

A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00881205
• Other study ID #: CENA713DDE18
• Status: Terminated
• Phase: Phase 4
• First received: April 14, 2009
• Last updated: March 8, 2012
• Start date: April 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Aalen
Germany	Novartis Investigative Site	Abensberg
Germany	Novartis Investigative Site	Achim
Germany	Novartis Investigative Site	Alzenau
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	Böblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Eisenach
Germany	Novartis Investigative Site	Ellwangen
Germany	Novartis Investigative Site	Erbach
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 Investigational Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Itzehoe
Germany	Novartis Investigative Site	Kaltenkirchen
Germany	Novartis Investigative Site	Koeln
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
Germany	Novartis Investigative Site	Oldenburg
Germany	Novartis Investigative Site	Osnabruck
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population	The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.	After 16 weeks of treatment	No