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
Results First Received: January 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Multiple Sclerosis
Cognitive Impairment
Interventions: Drug: Rivastigmine transdermal patch
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rivastigmine 5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
Placebo Matching the size, shape and color of rivastigmine patches.

Participant Flow:   Overall Study
    Rivastigmine     Placebo  
STARTED     45     41  
COMPLETED     34     34  
NOT COMPLETED     11     7  
Adverse Event                 8                 3  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 0                 1  
Administrative problems                 1                 1  
Condition no longer requires drug                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivastigmine 5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
Placebo Matching the size, shape and color of rivastigmine patches.
Total Total of all reporting groups

Baseline Measures
    Rivastigmine     Placebo     Total  
Number of Participants  
[units: participants]
  43     38     81  
Age  
[units: years]
Mean ± Standard Deviation
  44.6  ± 9.4     44.0  ± 7.3     44.3  ± 8.5  
Gender  
[units: participants]
     
Female     23     20     43  
Male     20     18     38  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated early due to low recruitment numbers. This study did not have the anticipated 80% power.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


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