Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
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Purpose
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 |
|---|---|---|
|
Multiple Sclerosis |
Drug: estroprogestins Drug: interferon-beta 1a |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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 |
- 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,
- 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
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| 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" |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00151801 History of Changes |
| Other Study ID Numbers: | NEU - PIL - 03 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by S. Andrea Hospital:
|
multiple sclerosis estroprogestins interferon-beta sex hormones MRI |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta Interferons Interferon beta 1a |
Ethinyl Estradiol Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013