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

September 8, 2005 updated by: S. Andrea Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00100
        • Recruiting
        • Department of Neurology - University of Rome La Sapienza
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabiana Marinelli, MD
        • Sub-Investigator:
          • Laura De Giglio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU - PIL - 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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