NCT00151801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started May 2002

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 9, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisestroprogestinsinterferon-betasex hormonesMRI

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

estroprogestinsDRUG
interferon-beta 1aDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology - University of Rome La Sapienza

Rome, Rome, 00100, Italy

RECRUITING

Related Publications (9)

  • 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. doi: 10.1136/jnnp.67.2.148.

    PMID: 10406979BACKGROUND

  • Zorgdrager A, De Keyser J. Menstrually related worsening of symptoms in multiple sclerosis. J Neurol Sci. 1997 Jul;149(1):95-7. doi: 10.1016/s0022-510x(97)05396-3.

    PMID: 9168172BACKGROUND

  • 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. doi: 10.1111/j.1600-0404.1999.tb00663.x.

    PMID: 10071166BACKGROUND

  • 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. doi: 10.1212/wnl.52.6.1230.

    PMID: 10214749BACKGROUND

  • Hernan 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. doi: 10.1212/wnl.55.6.848.

    PMID: 10994007BACKGROUND

  • 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.

    PMID: 9820297BACKGROUND

  • 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.

    PMID: 8615603BACKGROUND

  • 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. doi: 10.1046/j.1468-1331.2003.00519.x.

    PMID: 12535003BACKGROUND

  • 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.

    PMID: 27995531DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Valentina Tomassini, MD

    Department of Neurological Science University of Rome "La Sapienza"

    STUDY CHAIR

  • Fabiana Marinelli, MD

    Department of Neurological Science, University of Rome "La Sapienza"

    PRINCIPAL INVESTIGATOR

  • Carlo Pozzilli, MD

    Department of Neurological Science, University of Rome "La Sapienza"

    STUDY DIRECTOR

Central Study Contacts

Carlo Pozzilli, MD

CONTACT

+39-06-49914716carlo.pozzilli@uniroma1.it

Fabiana Marinelli, MD

CONTACT

+39-338-2955443fabiana.marinelli@uniroma1.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

May 1, 2002

Study Completion

December 1, 2008

Last Updated

September 9, 2005

Record last verified: 2005-09

Locations

IT(1)