A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104143
Recruitment Status : Withdrawn
First Posted : February 24, 2005
Last Update Posted : August 24, 2016
Information provided by:
Hoffmann-La Roche

Brief Summary:
This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: A4I Antagonist Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.
Study Start Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period

Secondary Outcome Measures :
  1. No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-59 years of age;
  • relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria);
  • >=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment;
  • EDSS score of <=6.5;
  • inadequate response to approved treatment(Canada only).

Exclusion Criteria:

  • MS attack within 1 month before enrollment;
  • systemic corticosteroids within 1 month before enrollment;
  • MS treatments (non-symptomatic) within specified periods before enrollment;
  • an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.

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 identifier (NCT number): NCT00104143

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche Identifier: NCT00104143     History of Changes
Other Study ID Numbers: NN18344
First Posted: February 24, 2005    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

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