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

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ClinicalTrials.gov Identifier: NCT00151801

Recruitment Status : Unknown

Verified September 2005 by S. Andrea Hospital.
Recruitment status was: Recruiting

First Posted : September 9, 2005

Last Update Posted : September 9, 2005

Sponsor:

Information provided by:

S. Andrea Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: estroprogestins Drug: interferon-beta 1a	Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Treatment
Official Title:	Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Study Start Date :	May 2002
Study Completion Date :	December 2008

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon Interferon beta Interferon beta-1a Avonex

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151801

Contacts


Contact: Carlo Pozzilli, MD	+39-06-49914716	carlo.pozzilli@uniroma1.it
Contact: Fabiana Marinelli, MD	+39-338-2955443	fabiana.marinelli@uniroma1.it

Locations


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

Sponsors and Collaborators

S. Andrea Hospital

Investigators


Study Chair:	Valentina Tomassini, MD	Department of Neurological Science University of Rome "La Sapienza"
Principal Investigator:	Fabiana Marinelli, MD	Department of Neurological Science, University of Rome "La Sapienza"
Study Director:	Carlo Pozzilli, MD	Department of Neurological Science, University of Rome "La Sapienza"

More Information

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.

Hernán 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00151801 History of Changes
Other Study ID Numbers:	NEU - PIL - 03
First Posted:	September 9, 2005 Key Record Dates
Last Update Posted:	September 9, 2005
Last Verified:	September 2005

Keywords provided by S. Andrea Hospital:


multiple sclerosis estroprogestins interferon-beta sex hormones MRI

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons Interferon-beta	Interferon beta-1a Ethinyl Estradiol Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

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