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Описание
Краткое названиеA Study for Patients With Relapsing Remitting Multiple Sclerosis
Полное названиеA Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
СпонсорEli Lilly and Company
Industry
ИсточникEli Lilly and Company
Под контролемUnited 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
Yes
Краткое описаниеThe purpose of this study is to test if dirucotide is safe and effective in treating
patients with relapsing remitting multiple sclerosis.
СостояниеЗавершено
Дата началаNovember 2006
ФазаPhase 2/Phase 3
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion 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 ??-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
ПолBoth
Минимальный возраст18 Years
Максимальный возраст50 Years
УсловиеRelapsing Remitting Multiple Sclerosis
Применяемое лечение
Drugdirucotide
Drugplacebo
Контакты и расположение
Vinnitsa Vinnitsa State Medical University
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