Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment (EXCITING)

This study has been terminated.
(Termination of study due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00881205
First received: April 14, 2009
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Cognitive Impairment
Drug: Rivastigmine transdermal patch
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881205

  Show 49 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00881205     History of Changes
Other Study ID Numbers: CENA713DDE18
Study First Received: April 14, 2009
Results First Received: January 20, 2012
Last Updated: March 8, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Multiple Sclerosis
Cognition
Rivastigmine
Patch

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014