A Study for Patients With Relapsing Remitting Multiple Sclerosis

NCT ID: NCT00869986

Last Updated: 2010-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-09-30

Brief Summary

The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dirucotide

Group Type: EXPERIMENTAL

dirucotide

Intervention Type: DRUG

500mg, intravenous, every 6 months for 15 months

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

intravenous, once every six months for 15 months

Interventions

dirucotide

500mg, intravenous, every 6 months for 15 months

Intervention Type: DRUG

placebo

intravenous, once every six months for 15 months

Intervention Type: DRUG

Other Intervention Names

MBP8298; LY2820671

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, 18-50 years of age

2. Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)

3. At least 2 years history of MS before trial entry

4. Documented history of 2 or more exacerbations in the 2 years prior to trial entry

5. Stable neurological status for at least 30 days before first study drug administration

6. Have an EDSS from 0-5.5

7. If female, she must either

• be post-menopausal or surgically sterilized; or
• use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
• be neither pregnant nor breast-feeding

8. Willingness and ability to comply with the protocol for the duration of the study

9. In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations

10. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements

Exclusion Criteria

1. Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)

2. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma

3. Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),

4. Clinically significant ECG abnormalities at screening

5. Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)

6. Have current autoimmune disease, compromised immune function or infection

7. History of allergic reactions to glatiramer acetate

8. Steroid therapy within 30 days prior to first study specific procedure, or any other treatment known to be used for putative or experimental MS treatment

9. Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test

10. Therapy with mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment

11. Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,

12. Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA

13. Participation in any other trial of an investigational agent within 90 days prior to screening

14. History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening

15. 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

16. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioMS Technology Corp.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Military Medical Academy

Sofia, , Bulgaria

Silesian Medical School

Katowice, , Poland

Clinical City Hospital No. 11

Moscow, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

FNsP J A Reimana

Prešov, , Slovakia

Vinnitsa State Medical University

Vinnitsa, , Ukraine

Countries

Bulgaria; Poland; Russia; Serbia; Slovakia; Ukraine

Other Identifiers

I3E-BM-MSAE

Identifier Type: -

Identifier Source: secondary_id

2006-001947-70

Identifier Type: -

Identifier Source: secondary_id

MBP8298-RR01

Identifier Type: -

Identifier Source: secondary_id

12791

Identifier Type: -

Identifier Source: org_study_id