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

This study has been completed.
Sponsor:
Collaborator:
BioMS Technology Corp.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00869986
First received: March 24, 2009
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: dirucotide
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Annualized relapse rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS) [ Time Frame: baseline, 15, 24 and 27 months ] [ Designated as safety issue: No ]
  • Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: baseline, 15, 24 and 27 months ] [ Designated as safety issue: No ]
  • Proportion of patients relapse-free [ Time Frame: 15, 24, and 27 months ] [ Designated as safety issue: No ]
  • Activity analysis of T2 and Gadolinium enhancing lesions [ Time Frame: 15 and 27 months ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: November 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dirucotide Drug: dirucotide
500mg, intravenous, every 6 months for 15 months
Other Names:
  • MBP8298
  • LY2820671
Placebo Comparator: Placebo Drug: placebo
intravenous, once every six months for 15 months

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869986

Locations
Bulgaria
Military Medical Academy
Sofia, Bulgaria
Poland
Silesian Medical School
Katowice, Poland
Russian Federation
Clinical City Hospital No. 11
Moscow, Russian Federation
Serbia
Clinical Center of Serbia
Belgrade, Serbia
Slovakia
FNsP J A Reimana
Presov, Slovakia
Ukraine
Vinnitsa State Medical University
Vinnitsa, Ukraine
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00869986     History of Changes
Other Study ID Numbers: 12791, I3E-BM-MSAE, 2006-001947-70, MBP8298-RR01
Study First Received: March 24, 2009
Last Updated: September 7, 2010
Health Authority: United States: Food and Drug Administration
Bulgaria: Ministry of Health
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014