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Interferon ß-1b Treatment by Cyclical Administration

NCT00270816 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Italian Multiple Sclerosis Foundation

    collaborator OTHER

  • S. Andrea Hospital

    lead OTHER

Principal Investigators

  • Marco Salvetti, MD · S.Andrea Hospital, University of Rome "La Sapienza"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2010-08-31
Completion
2011-01-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00270816 on ClinicalTrials.gov