Interferon ß-1b Treatment by Cyclical Administration

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00270816
• Date of registration: 27/12/2005
• Prospective Registration: No
• Primary sponsor: S. Andrea Hospital
• Public title: Interferon ß-1b Treatment by Cyclical Administration
• Scientific title: Effect of Cyclical Administration of Interferon ß-1b in Multiple Sclerosis - Comparison With Normal Dose.
• Date of first enrolment: November 2005
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00270816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Italy

Contacts

• Name: Marco Salvetti, MD
• Affiliation: S.Andrea Hospital, University of Rome "La Sapienza"

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Interferon ß-1b

Drug: Interferon-ß-1b

Primary Outcome(s)

number of gad-enhancing lesions (CELs) in T1 [Time Frame: baseline and after 12 months]

Secondary Outcome(s)

number of new and enlarging T2 lesions [Time Frame: baseline and after 12 months]

volume of T1 lesions (black holes) [Time Frame: baseline and after 12 months]

relapse rate [Time Frame: baseline and after 12 months]

Secondary ID(s)

NEU - CYC - 06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Italian Multiple Sclerosis Foundation