Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- estroprogestins
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters
SafetyRelapse rate at 6, 12, 18 and 24 months,
RelapsesEDSS progression at 12 and 24 months,
Disability progressionMS functional composite score at 12 and 24 months,
Other measures (7)
Number and volume of new gad-enhancing lesions at 12 and 24 months
MRI lesionsNumber of new T1 and T2 lesions at 12 and 24 months
MRI lesionsBrain volume changes at 12 and 24 months
Brain volume lossNeuropsychological examination at 0, 12, 24 months
Hamilton scale for depression score at 0, 12, 24 months
Mood and sleepMS Quality of Life scale score(MSQOL54)at 0, 12, 24 months
Quality of life (reported by participants)Fatigue Severity Scale score at 0, 12, 24 months
Fatigue
Who could take part
Relapsing MS · 18 to 40
Inclusion Criteria: * Female patients * 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: * History of migraine or thromboembolic events * 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Effect on Cognition of Estroprogestins Combined with Interferon Beta in Multiple Sclerosis: Analysis of Secondary Outcomes from a Randomised Controlled Trial.CNS Drugs · 2017
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.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.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.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.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.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.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.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.
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History
Started
May 2002
Finished
Dec 2008
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