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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by S. Andrea Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT00151801
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by S. Andrea Hospital:

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

Estimated Enrollment: 200
Study Start Date: May 2002
Estimated Study Completion Date: December 2008
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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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 July 22, 2014