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Sponsored by: |
S. Andrea Hospital |
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Information provided by: | S. Andrea Hospital |
ClinicalTrials.gov Identifier: | NCT00151801 |
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 | Intervention | Phase |
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Multiple Sclerosis |
Drug: estroprogestins Drug: interferon-beta 1a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | December 2008 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carlo Pozzilli, MD | +39-06-49914716 | carlo.pozzilli@uniroma1.it |
Contact: Fabiana Marinelli, MD | +39-338-2955443 | fabiana.marinelli@uniroma1.it |
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 |
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" |
Study ID Numbers: | NEU - PIL - 03 |
Study First Received: | September 8, 2005 |
Last Updated: | September 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00151801 History of Changes |
Health Authority: | Italy: Ministry of Health |
multiple sclerosis estroprogestins interferon-beta sex hormones MRI |
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate Hormones Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis Estradiol 3-benzoate Interferon beta 1a Polyestradiol phosphate |
Autoimmune Diseases of the Nervous System Estrogens Autoimmune Diseases Demyelinating Diseases Interferons Interferon-beta Adjuvants, Immunologic Ethinyl Estradiol Sclerosis Antiviral Agents Angiogenesis Inhibitors Estradiol Demyelinating Autoimmune Diseases, CNS |
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Multiple Sclerosis Therapeutic Uses Interferon beta 1a Growth Inhibitors Angiogenesis Modulating Agents Autoimmune Diseases of the Nervous System |
Estrogens Autoimmune Diseases Immune System Diseases Demyelinating Diseases Growth Substances Interferons Nervous System Diseases Adjuvants, Immunologic Interferon-beta Ethinyl Estradiol Sclerosis Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Demyelinating Autoimmune Diseases, CNS |