Trial intelligence / Profile preview

Dirucotide Safety Follow-on in SPMS

NCT00870155Phase 3

Key facts

Status: Terminated
Start: Feb 2007
Primary completion: Sep 2009
Countries: 10
Sponsor: Eli Lilly and Company
Modality: Peptides

Drugs: dirucotide
Conditions: secondary-progressive multiple sclerosis (SPMS)

Overview

Phase 3, open-label, single-arm trial of dirucotide in secondary-progressive multiple sclerosis (SPMS), sponsored by Eli Lilly and Company. Primary endpoint: Adverse Events, ECG, Laboratory, and Physical Exam Outcomes. Started Feb 2007; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Dirucotide
Dirucotide 500mg IV every 6 months

Who it enrols

Patients who completed the MBP8298-01 study, without concomitant MS therapies.

Endpoints

Primary

Adverse Events, ECG, Laboratory, and Physical Exam Outcomesevery 6 months

Secondary

Kurtzke Expanded Disability Status Scaleevery 6 months
Brain Atrophy by MRIevery 6 months
Activity Analysis of T2 and Gadolinium Enhancing Lesionsevery 6 months
Lesion Burdenevery 6 months
Multiple Sclerosis Functional Composite Indexevery 6 months
Relapse Ratesevery 6 months
Quality of Life (SF-36 or MSQoL54)every 6 months

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