Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis - Study Results

Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis (STAYCIS)

This study has been completed.

Study NCT00094172 Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

First Received on October 14, 2004. Last Updated on September 29, 2011 History of Changes

Results First Received: September 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Multiple Sclerosis
Interventions:	Drug: Atorvastatin 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
Fourteen centers enrolled 83 participants and randomized 82 participants(one participant voluntarily withdrew prior to randomization) who had experienced clinically isolated syndrome and were at risk for developing Multiple Sclerosis (MS) (two or more lesions on Magnetic Resonance Image (MRI) scans) between February 14, 2005 and July 24, 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At a screening visit, participants underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. Participants then signed an informed consent form.

Reporting Groups

	Description
Atorvastatin	Experimental
Placebo	Non-Active Comparator

Participant Flow: Overall Study

	Atorvastatin	Placebo
STARTED	50 ^[1]	32 ^[2]
COMPLETED	36	25
NOT COMPLETED	14	7
Adverse Event	0	1
Lost to Follow-up	2	0
Protocol Violation	0	1
Withdrawal by Subject	10	5
Primary endpoint met.	1	0
Started other MS therapy due to disease	1	0

[1]	Safety Sample: 49; Intent-to-Treat Sample: 49; Per Protocol Sample: 39
[2]	Safety Sample: 32; Intent-to-Treat Sample: 32; Per Protocol Sample: 28

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Atorvastatin	Experimental
Placebo	Non-Active Comparator

Baseline Measures

	Atorvastatin	Placebo	Total
Number of Participants [units: participants]	50	32	82
Age [units: years] Mean ± Standard Deviation	33.6 ± 9.4	33.9 ± 8.6	33.7 ± 9.0
Gender [units: participants]
Female	40	23	63
Male	10	9	19
Region of Enrollment [units: participants]
United States	46	29	75
Canada	4	3	7
Number of T2 Lesions at Baseline ^[1] [units: Lesion Count] Mean ± Standard Deviation	21.6 ± 17.6	19.5 ± 16.5	20.8 ± 17.1
Number of Gd+ Lesions at Baseline ^[2] [units: Lesion Count] Mean ± Standard Deviation	0.7 ± 2.7	0.2 ± 0.5	0.5 ± 2.1

[1]	Number of T2 lesions[1] at baseline. A higher score indicates more severe disease. [1] A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. Each T2 lesion is visible on at least one brain slice with a surface area ≥ 3mm^2 in plane
[2]	Number of gadolinium-enhancing (Gd+)[1] lesions at baseline. A higher score indicates more severe disease. [1]Gd+ lesions are measured on T1 weighted images after injection of 0.1 mM/kg of gadolinium pentate.

[1]

Number of T2 lesions[1] at baseline. A higher score indicates more severe disease.

[1] A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. Each T2 lesion is visible on at least one brain slice with a surface area ≥ 3mm^2 in plane

[2]

Number of gadolinium-enhancing (Gd+)[1] lesions at baseline. A higher score indicates more severe disease.

[1]Gd+ lesions are measured on T1 weighted images after injection of 0.1 mM/kg of gadolinium pentate.

Outcome Measures

Show All Outcome Measures

1. Primary:

The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months. [ Time Frame: 12 months post-randomization ]

Show Outcome Measure 1

2. Secondary:

Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria [ Time Frame: 12 months post-randomization ]

Show Outcome Measure 2

3. Secondary:

Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria [ Time Frame: 18 months post-randomization ]

Show Outcome Measure 3

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 NOT 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.

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
No text entered.

Results Point of Contact:

Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov

No publications provided

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00094172 History of Changes
Other Study ID Numbers:	DAIT ITN020AI
Study First Received:	October 14, 2004
Results First Received:	September 29, 2011
Last Updated:	September 29, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board