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Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients

Information source: S. Andrea Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: estroprogestins (Drug); interferon-beta 1a (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: S. Andrea Hospital

Official(s) and/or principal investigator(s):
Valentina Tomassini, MD, Study Chair, Affiliation: Department of Neurological Science University of Rome "La Sapienza"
Fabiana Marinelli, MD, Principal Investigator, Affiliation: Department of Neurological Science, University of Rome "La Sapienza"
Carlo Pozzilli, MD, Study Director, Affiliation: Department of Neurological Science, University of Rome "La Sapienza"

Overall contact:
Carlo Pozzilli, MD, Phone: +39-06-49914716, Email: carlo.pozzilli@uniroma1.it

Summary

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.

Clinical Details

Official title: Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

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,

Secondary outcome:

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

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

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Carlo Pozzilli, MD, Phone: +39-06-49914716, Email: carlo.pozzilli@uniroma1.it

Department of Neurology - University of Rome La Sapienza, Rome 00100, Italy; Recruiting
Carlo Pozzilli, MD, Phone: +39-06-49914716, Email: carlo.pozzilli@uniroma1.it
Fabiana Marinelli, MD, Phone: +39-338-2955443, Email: fabiana.marinelli@uniroma1.it
Fabiana Marinelli, MD, Principal Investigator
Laura De Giglio, MD, Sub-Investigator
Additional Information

Related publications:

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.

Zorgdrager A, De Keyser J. Menstrually related worsening of symptoms in multiple sclerosis. J Neurol Sci. 1997 Jul;149(1):95-7.

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.

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.

HernĂ¡n 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.

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. Erratum in: Lancet 1999 Feb 20;353(9153):678.

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.

Starting date: May 2002
Last updated: September 8, 2005

Page last updated: August 20, 2015

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