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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)

This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 13, 2005
Last updated: July 29, 2016
Last verified: July 2016
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 Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: MK0812
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 120
Study Start Date: August 2004
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00239655

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00239655     History of Changes
Other Study ID Numbers: 0812-003
Study First Received: October 13, 2005
Last Updated: July 29, 2016

Additional relevant MeSH terms:
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 processed this record on May 25, 2017