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Multiple SclerosisPhase 4EXCITINGNCT00881205

Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

A Phase 4 study testing Rivastigmine transdermal patch in people with Multiple Sclerosis and Cognitive Impairment, run by Novartis Pharmaceuticals at 49 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Cognitive Impairment
What is being tested?
Rivastigmine transdermal patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
49 sitesGermany
Study dates
Apr 2009to Jan 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

Germany49 sites

  • Novartis Investigative Site

    Aachen, 52062

  • Novartis Investigative Site

    Aalen, 73430

  • Novartis Investigative Site

    Abensberg, 93326

  • Novartis Investigative Site

    Achim, 28832

  • Novartis Investigative Site

    Alzenau in Unterfranken, 63755

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Bad Mergentheim, 97980

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 10178

  • Novartis Investigative SIte

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 12103

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Böblingen, 71034

  • Novartis Investigative Site

    Bochum, 44892

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Eisenach, 99817

  • Novartis Investigative Site

    Ellwangen, 73479

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Essen, 45138

  • Novartis Investigative Site

    Giessen, 35385

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22083

  • Novartis Investigational Site

    Hamburg, 22179

  • Novartis Investigative Site

    Hanover, 30623

  • Novartis Investigative Site

    Itzehoe, 25524

  • Novartis Investigative Site

    Kaltenkirchen, 24568

  • Novartis Investigative Site

    Krefeld, 47798

  • Novartis Investigative Site

    Lappersdorf, 93138

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04157

  • Novartis Investigative Site

    Ludwigshafen, 67059

  • Novartis Investigative Site

    Lüneburg, 21335

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neuburg am Inn, 86633

  • Novartis Investigative Site

    Oldenburg, 26122

  • Novartis Investigative Site

    Osnabrück, 49078

  • Novartis Investigative Site

    Rostock, 18147

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stuttgart, 70182

  • Novartis Investigative Site

    Stuttgart, 70191

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Unterhaching, 82008

  • Novartis Investigative Site

    Viernheim, 69518

  • Novartis Investigative Site

    Wiesbaden, 65183

  • Novartis Investigative Site

    Wolfratshausen, 82515

Other trials in Germany

About this study

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

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.

Being tested
Rivastigmine transdermal patch, Placebo
Keywords
Multiple Sclerosis, Cognition, Rivastigmine, Patch
Medical subject headings
Multiple Sclerosis, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivastigmine transdermal patchDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT00881205
Study groupRoleWhat they receive
RivastigmineExperimentalRivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
Receives: Drug: Rivastigmine transdermal patch
PlaceboPlacebo comparatorPlacebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After 16 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionJan 2011
  4. Study completionJan 2011

Why it stopped: Termination of study due to low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881205
Sponsor's protocol ID
CENA713DDE18
Acronym
EXCITING
Status last verified
Mar 2012
First submitted
14 Apr 2009
Last updated
12 Mar 2012

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivastigmine transdermal patch in people with Multiple Sclerosis and Cognitive Impairment, run by Novartis Pharmaceuticals at 49 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00881205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.

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