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)

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00239655
• Other study ID #: 0812-003
• Secondary ID: MK0812-0032005_0
• Status: Terminated
• Phase: Phase 2
• First received: October 13, 2005
• Last updated: July 29, 2016
• Start date: August 2004
• Est. completion date: January 2006

Study information

• Verified date: July 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: January 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• MK0812

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate of new GD-enhancing lesions as assessed by MRI		3 Months	No
Secondary	Volume and cumulative number of new persistent Gd-enhancing lesions		3 Months	No