Interferon ß-1b Treatment by Cyclical Administration

This study has been completed.
Sponsor:
Collaborator:
Multiple Sclerosis Italian Foundation (FISM)
Information provided by:
S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT00270816
First received: December 27, 2005
Last updated: February 10, 2014
Last verified: December 2013

December 27, 2005
February 10, 2014
November 2005
February 2011   (final data collection date for primary outcome measure)
  • number of lesions in T1 and new lesions in T2 [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • number of gad-enhancing lesions in T1 [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • number of lesions in T1 and new lesions in T2
  • number of gad-enhancing lesions in T1
Complete list of historical versions of study NCT00270816 on ClinicalTrials.gov Archive Site
  • relapse rate [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • volume of T1 lesions (black holes) [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • relapse rate
  • volume of T1 lesions (black holes)
Not Provided
Not Provided
 
Interferon ß-1b Treatment by Cyclical Administration
Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.

The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Interferon-ß-1b
    250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
  • Drug: Interferon ß-1b
    250 micrograms (8 MIU) administered subcutaneously (sc) every other day
  • Experimental: interferon beta cyclical administration
    Interferon ß-1b Treatment by Cyclical Administration
    Intervention: Drug: Interferon-ß-1b
  • Active Comparator: Interferon ß-1b Treatment
    Interferon ß-1b Treatment
    Intervention: Drug: Interferon ß-1b

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2013
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients affected by remitting Multiple Sclerosis who had at least a relapse in the last year of the disease.
  • Satisfying general clinical conditions according to the researcher. Adequate hepatic function. Capacity to use adequate contraceptive techniques during the study.

Exclusion Criteria:

  • Any other disease that might better explain signs and symptoms of the patient.
  • Any other disability condition that might interfere with the clinical evolution.
  • History of hypersensitivity to natural or recombinant interferon or to human albumin.
  • Clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure.
  • Not adequately controlled epilepsy.
  • Inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study.
  • Previous therapies modifying the disease course in the last six months.
  • Steroid therapies in the last 3 months.
  • Pregnancy, lactation, serological positivity to the pregnancy test during the screening period.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00270816
NEU - CYC - 06
Yes
Marco Salvetti, CENTERS
S. Andrea Hospital
Multiple Sclerosis Italian Foundation (FISM)
Study Director: Marco Salvetti, MD S.Andrea Hospital, University of Rome "La Sapienza"
S. Andrea Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP