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

Completed · Phase 2

Conditions studied: HTLV-I Infection, Spinal Cord Disease, Tropical Spastic Paraparesis

In brief

HTLV stands for human T cell leukemia virus. HTLV-1 is a virus that attacks specific kinds of white blood cells called T cells. T cells are part of the natural defense system of the body. HTLV-1 has been associated with leukemia and lymphoma. In addition, approximately 1% of all patients infected with HTLV-1 develops a condition known as HTLV-1 associated myelopathy (HAM) / tropical spastic paraparesis (TSP). Currently there is no clearly defined, effective treatment for patients with HAM/TSP. Steroids have been used as therapy but have only been able to provide temporary relief of symptoms. Human interferon is a small protein released from different kinds of cells in the body. Interferon has been known to have antiviral and immunological effects and has been used to treat hepatitis and multiple sclerosis. Interferon Beta is released from cells called fibroblasts. These cells play a role in the production of connective tissue. The purpose of this study is to evaluate the possible role of recombinant interferon beta (Avonex) in treatment of HAM/TSP. The study is broken into three phases, a pre-treatment phase, a treatment phase, and a post-treatment phase. The total duration of the study will be 44 weeks. Patients participating in this study will receive injections of Avonex 1 to 2 times a week. Throughout the study patients will regularly submit blood samples and undergo diagnostic tests such as MRI and measures of somatosensory evoked potentials.

Key facts

Study ID: NCT00001785
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 12
Starts: 1998-09-01
Expected to finish: 2004-09-01
Last updated by the study team: 2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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