NCT00870155

Brief Summary

To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
9 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

2.6 years

First QC Date

March 26, 2009

Last Update Submit

September 7, 2010

Conditions

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes

    every 6 mos

Secondary Outcomes (7)

  • Degree of change in Kurtzke Expended Disability Status (EDSS)

    every 6mos

  • Brain atrophy by MRI

    every 6mos

  • Activity analysis of T2 and Gadolinium enhancing lesions

    every 6mos

  • Lesion burden

    every 6mos

  • Degree of change in MS Functional Composite Index (MSFC)

    every 6mos

  • +2 more secondary outcomes

Study Arms (1)

Dirucotide

EXPERIMENTAL
Drug: dirucotide

Interventions

dirucotideDRUG

500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination

Also known as: MBP8298, LY2820671
Dirucotide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis",
  • Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
  • In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.

You may not qualify if:

  • Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
  • Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
  • Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
  • Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

St. Michaels Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Terveystalo Turku Kuvantaminen

Turku, 20101, Finland

Location

Heinrich Heine Universitaets

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Vecmilgravis Hospital

Riga, 1015, Latvia

Location

Maaslandziekenhuis

Sittard, 6131BK, Netherlands

Location

Hospital Duran I Reynals

Barcelona, 08907, Spain

Location

Karolinska Universitetssjukhus

Stockholm, 14186, Sweden

Location

Walton Hospital

Liverpool, L97LJ, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

MBP-8298

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

February 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations

LA(1)ES(1)DE(1)CA(1)FI(1)DK(1)NL(1)SE(1)GB(1)