A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00239655
First received: October 13, 2005
Last updated: May 14, 2008
Last verified: May 2008

October 13, 2005
May 14, 2008
August 2004
January 2006   (final data collection date for primary outcome measure)
Accrual rate of new GD-enhancing lesions as assessed by MRI [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00239655 on ClinicalTrials.gov Archive Site
Volume and cumulative number of new persistent Gd-enhancing lesions [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)
A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI

The purpose of this study is to test MK0812 on disease activity in patients with relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain lesions via MRI brain scans and an open label extension is offered.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
Drug: MK0812
Other Name: MK0812
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
January 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have clinically definite relapsing-remitting MS onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year OR a recent clinically isolated syndrome suggestive of MS occurring 3-12 months before screening
  • Patients must be relatively healthy

Exclusion Criteria:

  • Patient has primary progressive MS
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00239655
2005_087, MK0812-003
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP