Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001785
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Recombinant Human Interferon Beta-1a (Avonex) for the Treatment of Patients With HTLV-1-Associated Myelopathy (HAM)
• Scientific title: Combined Virological and Immunological Evaluation of Treatment of Patients With Early HTLV-1-Associated Myelopathy With Recombinant Human Interferon Beta-1a
• Date of first enrolment: September 1998
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001785
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

patients entering this study will:

be at least 16 years old;

meet diagnostic criteria for HAM/TSP as defined by the WHO and current literature;

have progression of the clinical symptoms during the past 12 months;

have an EDSS of less than or equal to 7;

have spontaneous in vitro lymphoproliferation;

able to provide written informed consent;

able to comply with protocol requirements;

if a females, be not of a child bearing potential or if of child bearing potential
documented to be non-pregnant by urine pregnancy test with adequate counseling and
contraception.

EXCLUSION CRITERIA:

Patients entering this study will not:

be pregnant or lactating;

be HIV, HCV, or hepatitis B surface antigen positive;

have a significant medical condition that in the opinion of the investigator would
compromise the safety of the patient;

have a history of suicidal ideations and no major depressive event (DSM-IV) within 3
months of enrollment;

have used an investigational medication or steroids within 90 days of the enrollment
visit;

have a history of an allergic reaction to albumin;

have metallic fragments, ferromagnetic surgical clips, and implanted electronic devices
(cardiac pace makers, vagal nerve stimulators);

drug abuse.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tropical Spastic Paraparesis

HTLV-I Infection

Spinal Cord Disease

Intervention(s)

Drug: Recombinant human interferon beta-1a

Secondary ID(s)

98-N-0160

980160

Source(s) of Monetary Support

Please refer to primary and secondary sponsors