Clinical trial NCT00869986: A Study for Patients With Relapsing Remitting Multiple Sclerosis
Official title: A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: BioMS Technology Corp.
First posted: 2009-03-26
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Annualized relapse rate
timeFrame: 15 months
Secondary outcomes:
measure: Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
timeFrame: baseline, 15, 24 and 27 months
measure: Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
timeFrame: baseline, 15, 24 and 27 months
measure: Proportion of patients relapse-free
timeFrame: 15, 24, and 27 months
measure: Activity analysis of T2 and Gadolinium enhancing lesions
timeFrame: 15 and 27 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Katowice
country: Poland
facility: Silesian Medical School
city: Moscow
country: Russian Federation
facility: Clinical City Hospital No. 11
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Presov
country: Slovakia
facility: FNsP J A Reimana
city: Vinnitsa
country: Ukraine
facility: Vinnitsa State Medical University
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: