A Study for Patients With Relapsing Remitting Multiple Sclerosis (MINDSET01)

A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: dirucotide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Military Medical Academy
• Poland
  • Katowice, Poland
    • Silesian Medical School
• Russian Federation
  • Moscow, Russian Federation
    • Clinical City Hospital No. 11
• Serbia
  • Belgrade, Serbia
    • Clinical Center of Serbia
• Slovakia
  • Presov, Slovakia
    • FNsP J A Reimana
• Ukraine
  • Vinnitsa, Ukraine
    • Vinnitsa State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; intravenous, once every six months for 15 months
EXPERIMENTAL: Dirucotide	Drug: dirucotide; 500mg, intravenous, every 6 months for 15 months; Other Names: MBP8298; LY2820671

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized relapse rate	15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)	baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)	baseline, 15, 24 and 27 months
Proportion of patients relapse-free	15, 24, and 27 months
Activity analysis of T2 and Gadolinium enhancing lesions	15 and 27 months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: BioMS Technology Corp.
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (ESTIMATE): March 26, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 7, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: 12791; I3E-BM-MSAE; 2006-001947-70; MBP8298-RR01