A Study for Patients With Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— MINDSET01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869986
• Other study ID #: 12791
• Secondary ID: I3E-BM-MSAE2006-
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 24, 2009
• Last updated: September 7, 2010
• Start date: November 2006
• Est. completion date: September 2009

Study information

• Verified date: September 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Ministry of HealthPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dirucotide
500mg, intravenous, every 6 months for 15 months
• placebo
intravenous, once every six months for 15 months

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	BioMS Technology Corp.

Countries where clinical trial is conducted

Bulgaria,  Poland,  Russian Federation,  Serbia,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized relapse rate		15 months	No
Secondary	Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)		baseline, 15, 24 and 27 months	No
Secondary	Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)		baseline, 15, 24 and 27 months	No
Secondary	Proportion of patients relapse-free		15, 24, and 27 months	No
Secondary	Activity analysis of T2 and Gadolinium enhancing lesions		15 and 27 months	No