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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

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

To Top