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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00104143

First received: February 23, 2005

Last updated: October 10, 2007

Last verified: October 2007

History of Changes

Purpose

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	Intervention	Phase
Multiple Sclerosis	Drug: A4I Antagonist	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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.

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period

Secondary Outcome Measures:

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

Study Start Date:

October 2007

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104143

Show 39 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00104143 History of Changes
Other Study ID Numbers:	NN18344
Study First Received:	February 23, 2005
Last Updated:	October 10, 2007
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013

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