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

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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104143

Enrollment

Registered

2005-02-24

Start date

2007-10-31

Completion date

Unknown

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

DRUGA4I Antagonist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period	—

Secondary

Measure	Time frame
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	—

Countries

Bulgaria, Canada, Czechia, Germany, Poland, Russia, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026