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Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.
The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.
The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.
Phase 2, randomised, single blind, three arms study.
Follow-up of 24 months.
The study will include relapsing-remitting multiple sclerosis female patients.
Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).
Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.
A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24.
MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle).
During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estroprogestins | Drug | |||
| interferon-beta 1a | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters | ||
| Relapse rate at 6, 12, 18 and 24 months, | ||
| EDSS progression at 12 and 24 months, | ||
| MS functional composite score at 12 and 24 months, |
| Measure | Description | Time Frame |
|---|---|---|
| Number and volume of new gad-enhancing lesions at 12 and 24 months | ||
| Number of new T1 and T2 lesions at 12 and 24 months | ||
| Brain volume changes at 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Pozzilli, MD | Contact | +39-06-49914716 | carlo.pozzilli@uniroma1.it | |
| Fabiana Marinelli, MD | Contact | +39-338-2955443 | fabiana.marinelli@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Tomassini, MD | Department of Neurological Science University of Rome "La Sapienza" | Study Chair |
| Fabiana Marinelli, MD | Department of Neurological Science, University of Rome "La Sapienza" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology - University of Rome La Sapienza | Recruiting | Rome | Rome | 00100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10406979 | Background | Hawkins SA, McDonnell GV. Benign multiple sclerosis? Clinical course, long term follow up, and assessment of prognostic factors. J Neurol Neurosurg Psychiatry. 1999 Aug;67(2):148-52. doi: 10.1136/jnnp.67.2.148. | |
| 9168172 | Background | Zorgdrager A, De Keyser J. Menstrually related worsening of symptoms in multiple sclerosis. J Neurol Sci. 1997 Jul;149(1):95-7. doi: 10.1016/s0022-510x(97)05396-3. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Not provided
| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Neuropsychological examination at 0, 12, 24 months |
| Hamilton scale for depression score at 0, 12, 24 months |
| MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months |
| Fatigue Severity Scale score at 0, 12, 24 months |
| Carlo Pozzilli, MD | Department of Neurological Science, University of Rome "La Sapienza" | Study Director |
| 10071166 | Background | Bansil S, Lee HJ, Jindal S, Holtz CR, Cook SD. Correlation between sex hormones and magnetic resonance imaging lesions in multiple sclerosis. Acta Neurol Scand. 1999 Feb;99(2):91-4. doi: 10.1111/j.1600-0404.1999.tb00663.x. |
| 10214749 | Background | Kim S, Liva SM, Dalal MA, Verity MA, Voskuhl RR. Estriol ameliorates autoimmune demyelinating disease: implications for multiple sclerosis. Neurology. 1999 Apr 12;52(6):1230-8. doi: 10.1212/wnl.52.6.1230. |
| 10994007 | Background | Hernan MA, Hohol MJ, Olek MJ, Spiegelman D, Ascherio A. Oral contraceptives and the incidence of multiple sclerosis. Neurology. 2000 Sep 26;55(6):848-54. doi: 10.1212/wnl.55.6.848. |
| 9820297 | Background | Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504. |
| 8615603 | Background | De Cicco Nardone F, Rossiello F, Iacopino F, Benedetto MT, Cinque B, Dell'Acqua S, Sica G. Effects of interferon-beta on steroid receptors, prostaglandins and enzymatic activities in human endometrial cancer. Anticancer Res. 1996 Jan-Feb;16(1):161-9. |
| 12535003 | Background | Pozzilli C, Tomassini V, Marinelli F, Paolillo A, Gasperini C, Bastianello S. 'Gender gap' in multiple sclerosis: magnetic resonance imaging evidence. Eur J Neurol. 2003 Jan;10(1):95-7. doi: 10.1046/j.1468-1331.2003.00519.x. |
| 27995531 | Derived | De Giglio L, Marinelli F, Barletta VT, Pagano VA, De Angelis F, Fanelli F, Petsas N, Pantano P, Tomassini V, Pozzilli C. Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial. CNS Drugs. 2017 Feb;31(2):161-168. doi: 10.1007/s40263-016-0401-0. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |