Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
NCT ID: NCT00151801
Last Updated: 2005-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2002-05-31
2008-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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estroprogestins
interferon-beta 1a
Eligibility Criteria
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Inclusion Criteria
* Clinically definite relapsing-remitting MS according to the McDonald criteria
* Age between 18-40 y.o.
* EDSS from 0 to 4.0, inclusive
Exclusion Criteria
* Reproductive system disorders
* Pregnancy or suspension of pregnancy within 12 months prior to randomisation
* Prior use of estroprogestins within the last 3 months prior to randomisation
* Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
* Prior use of immunomodulating drugs within the last 6 months prior to randomisation
* Prior use of corticosteroids within the last 3 months prior to randomisation
* Have clinical relapse 30 days prior to randomisation
18 Years
40 Years
FEMALE
No
Sponsors
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S. Andrea Hospital
OTHER
Principal Investigators
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Valentina Tomassini, MD
Role: STUDY_CHAIR
Department of Neurological Science University of Rome "La Sapienza"
Fabiana Marinelli, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurological Science, University of Rome "La Sapienza"
Carlo Pozzilli, MD
Role: STUDY_DIRECTOR
Department of Neurological Science, University of Rome "La Sapienza"
Locations
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Department of Neurology - University of Rome La Sapienza
Rome, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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Carlo Pozzilli, MD
Role: primary
Fabiana Marinelli, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NEU - PIL - 03
Identifier Type: -
Identifier Source: org_study_id