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

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00104143
• Other study ID #: NN18344
• Status: Withdrawn
• Phase: Phase 2
• First received: February 23, 2005
• Last updated: August 23, 2016
• Start date: October 2007

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• A4I Antagonist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Bulgaria,  Canada,  Czech Republic,  Germany,  Poland,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
Secondary	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