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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)(0812-003)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00239655
Recruitment Status : Terminated
First Posted : October 17, 2005
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: MK0812 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Accrual rate of new GD-enhancing lesions as assessed by MRI [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Volume and cumulative number of new persistent Gd-enhancing lesions [ Time Frame: 3 Months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239655


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00239655     History of Changes
Other Study ID Numbers: 0812-003
MK0812-003
2005_087
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases