Trial Outcomes & Findings for Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment (NCT NCT00881205)

Last Updated: 2012-03-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

86 participants

Primary outcome timeframe

After 16 weeks of treatment

Results posted on

2012-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45	41
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	8	3
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	0	1
Overall Study Administrative problems	1	1
Overall Study Condition no longer requires drug	1	0

Baseline Characteristics

Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rivastigmine n=43 Participants 5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,	Placebo n=38 Participants Matching the size, shape and color of rivastigmine patches.	Total n=81 Participants Total of all reporting groups
Age Continuous	44.6 years STANDARD_DEVIATION 9.4 • n=93 Participants	44.0 years STANDARD_DEVIATION 7.3 • n=4 Participants	44.3 years STANDARD_DEVIATION 8.5 • n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	20 Participants n=4 Participants	43 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	18 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: After 16 weeks of treatment

Population: Due to low enrollment numbers study did not achieve the anticipated 80% power.

Outcome measures

Outcome data not reported

Adverse Events

Total Patients

Serious events: 6 serious events

Other events: 48 other events

Deaths: 0 deaths

Rivastigmine

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Total Patients n=86 participants at risk Total Patients	Rivastigmine n=45 participants at risk Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size	Placebo n=41 participants at risk Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
Gastrointestinal disorders NAUSEA	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
General disorders OEDEMA PERIPHERAL	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
General disorders PYREXIA	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Infections and infestations CELLULITIS	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Infections and infestations PYELONEPHRITIS	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Infections and infestations SEPSIS	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Nervous system disorders DIZZINESS	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Nervous system disorders OPTIC NEURITIS	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Psychiatric disorders DEPRESSION	1.2% 1/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Total Patients n=86 participants at risk Total Patients	Rivastigmine n=45 participants at risk Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size	Placebo n=41 participants at risk Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
Ear and labyrinth disorders VERTIGO	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Gastrointestinal disorders DIARRHOEA	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Gastrointestinal disorders NAUSEA	7.0% 6/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	9.8% 4/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Gastrointestinal disorders VOMITING	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
General disorders CHILLS	2.3% 2/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
General disorders INFLUENZA LIKE ILLNESS	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Infections and infestations NASOPHARYNGITIS	8.1% 7/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	13.3% 6/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Infections and infestations RESPIRATORY TRACT INFECTION	2.3% 2/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	2.3% 2/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Nervous system disorders DIZZINESS	2.3% 2/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	11.6% 10/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	8.9% 4/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	14.6% 6/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Psychiatric disorders DEPRESSION	5.8% 5/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	9.8% 4/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders COUGH	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Skin and subcutaneous tissue disorders ERYTHEMA	15.1% 13/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	15.6% 7/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	14.6% 6/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Skin and subcutaneous tissue disorders PRURITUS	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Skin and subcutaneous tissue disorders RASH	8.1% 7/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	11.1% 5/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Skin and subcutaneous tissue disorders SKIN IRRITATION	2.3% 2/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	0.00% 0/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Skin and subcutaneous tissue disorders SKIN REACTION	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.2% 1/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.9% 2/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.
Vascular disorders HYPERTENSION	3.5% 3/86 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	4.4% 2/45 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.	2.4% 1/41 The safety population will consist of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment. Patients will be analyzed according to treatment received.