Status:
COMPLETED
Interferon ß-1b Treatment by Cyclical Administration
Lead Sponsor:
S. Andrea Hospital
Collaborating Sponsors:
Italian Multiple Sclerosis Foundation
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief 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. Abou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00270816
Start Date
November 1 2005
End Date
January 1 2011
Last Update
December 19 2018
Active Locations (1)
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1
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, Italy, 00139