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Interferon ß-1b Treatment by Cyclical Administration

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ClinicalTrials.gov Identifier: NCT00270816
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Italian Multiple Sclerosis Foundation
Information provided by (Responsible Party):
Giovanni Ristori, S. Andrea Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Interferon-ß-1b Drug: Interferon ß-1b Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.
Actual Study Start Date : November 2005
Primary Completion Date : August 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: interferon beta cyclical administration
Interferon ß-1b Treatment by Cyclical Administration
Drug: Interferon-ß-1b
250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
Active Comparator: Interferon ß-1b Treatment
Interferon ß-1b Treatment
Drug: Interferon ß-1b
250 micrograms (8 MIU) administered subcutaneously (sc) every other day



Primary Outcome Measures :
  1. number of lesions in T1 and new lesions in T2 [ Time Frame: baseline and after 12 months ]
  2. number of gad-enhancing lesions in T1 [ Time Frame: baseline and after 12 months ]

Secondary Outcome Measures :
  1. relapse rate [ Time Frame: baseline and after 12 months ]
  2. volume of T1 lesions (black holes) [ Time Frame: baseline and after 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270816


Locations
Italy
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, Italy, 00139
Sponsors and Collaborators
S. Andrea Hospital
Italian Multiple Sclerosis Foundation
Investigators
Study Director: Marco Salvetti, MD S.Andrea Hospital, University of Rome "La Sapienza"

Additional Information:
Publications:

Responsible Party: Giovanni Ristori, MD, S. Andrea Hospital
ClinicalTrials.gov Identifier: NCT00270816     History of Changes
Other Study ID Numbers: NEU - CYC - 06
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Giovanni Ristori, S. Andrea Hospital:
Multiple Sclerosis
Interferon-ß-1b
Therapy

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents