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Protocol Details

International Nested, Double Blind Placebo-Controlled Clinical Trial of Corticosteroids in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended
Gender: Male & Female
Min Age: 18
Max Age: 150

Referral Letter Required


Population Exclusion(s)


Special Instructions

Currently Not Provided


Neurological Disorder

Recruitment Keyword(s)



HTLV-1 Infection

Investigational Drug(s)


Investigational Device(s)



Drug: Methylprednisolone
Other: No intervention
Drug: Prednisolone
Drug: Prednisone

Supporting Site

National Institute of Neurological Disorders and Stroke


Steroids are drugs that decrease inflammation. Spinal cord swelling occurs in people with human T-cell lymphotrophic virus type 1 associated myelopathy/tropical spastic paraparesis (HAM/TSP). Researchers think the steroids prednisone and methylprednisolone could help them.


To see if steroids can slow the progression of HAM/TSP.


People ages 18 and older who:


Have finished screening under another protocol

Can walk 10 meters with or without walking sticks


Participants will be screened over 4 visits in 12 weeks with:

Medical history

Physical and neurological exams

Blood and urine tests

Brain and spine MRI: Participants lie on a table that slides into a metal cylinder.

They will get earplugs for loud sounds. They will get a contrast agent through an IV catheter. A needle guides a thin plastic tube into an arm vein.

Lumbar puncture (LP): A numbing agent is injected into the back. A needle inserted between bones in the back removes about 2 tablespoons of cerebrospinal fluid.

DEXA scan: Participants lie on a table while an x-ray scanner moves over the body.

Participants will be divided into 3 groups depending on symptoms.

Participants will have visits over 48 weeks.

These will include neurological exams, blood tests, 2 MRIs, and 2 LPs.

One group will have at least 8 visits. They will:

Receive methylprednisolone through an IV daily for 3 days in a row

Take steroid capsules daily for 24 weeks

One group will have at least 6 visits. They will:

Take either placebos or steroid capsules daily for 24 weeks

One group will have 4 visits over 48 weeks. They will not receive treatment.

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-18 years or older

-Diagnosis of HAM/TSP according to Belem Criteria

-Completed screening procedures under protocol 98-N-0047

-Able to walk 10 meters, without or with walking aid at onset of trial

-Willing and able to comply with all the aspects of trial design and follow-up

-Able to provide informed consent

-Women of child bearing potential willing to commit to the use of a reliable method of birth control (i.e., hormonal contraception including birth control pills, injected hormones or vaginal ring; intrauterine device; barrier methods with spermicide, specifically diaphragms or condoms; or they have undergone surgical sterilization, such as hysterectomy, or tubal ligation for the duration of the study.

-Patient has the following lab tests measured on screening labs (The NIH Department of Laboratory Medicine (DLM) normal ranges will be used; current normal values are included below for reference, but these values may change depending on the DLM):

--WBC (Male 4.23 - 9.07 times 10(3)/mcL, Female 3.98 - 10.04 times 10(3)/mcL) within the normal range

--Platelets greater than or equal to 100 times 10(3)/mcL (Male 161 - 347 x 10(3)/mcL, Female 173 - 369 times 10(3)/mcL)

--Hb greater than or equal to 8.0 g/dL (Male 13.7 - 17.5 g/dL, Female 11.2 - 15.7g/dL)

--AST less than or equal to 3 times upper limit of normal range (Male less than or equal to 40, Female less than or equal to 32)

--ALT less than or equal to 3 times upper limit of normal range (Male less than or equal to 41, Female less than or equal to 33)

--Serum CK levels less than or equal to 3 times upper limit of normal range (Male 39 308 U/L, Female 26 192 U/L)

--HBA1c less than or equal to 48 mmol/mol (6.5%) (4.0 6.0%)

--Negative serology for HIV, HBV, or HCV infection


-Pregnant or breastfeeding

-Alternative diagnoses that can explain neurological disability

-Patients with any type of ATLL

-Having received an investigational drug for HAM/TSP within 6 months prior to entering the study

-Having received corticosteroids or other immune-modulating or anti-viral agent that alter the immune response to HTLV-1 within 3 months of entering the study if rapid-progressor or within the last 12 months if slow or non-progressor

-Clinically significant medical disorders that, in the judgment of the investigators, expose the patient to undue risk of harm or prevent the patient from completing the study

-Uncontrolled diabetes

-Known untreated or currently treated active TB or latent TB, as diagnosed by specific local guidelines. Patient can be recruited 6 months after active TB or latent TB has been fully treated according to local guidelines

-Strongyloidis stercoralis infection: Patients from an endemic area will need to be screened for infection (by serology and stool analysis) and cleared or diagnosed and treated

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Croda MG, de Oliveira AC, Vergara MP, Bonasser F, Smid J, Duarte AJ, Casseb J. Corticosteroid therapy in TSP/HAM patients: the results from a 10 years open cohort. J Neurol Sci. 2008 Jun 15;269(1-2):133-7. doi: 10.1016/j.jns.2008.01.004. Epub 2008 Feb 6.

Pillat MM, Correa BL, da Rocha CF, M(SqrRoot) ller GC, Lopes RP, Lampert SS, Teixeira AL, Menna-Barreto M, Bauer ME. Changes in T cell phenotype and activated MAPKs are correlated to impaired cellular responses to antigens and glucocorticoids during HTLV-I infection. J Neuroimmunol. 2009 Nov 30;216(1-2):76-84. doi: 10.1016/j.jneuroim.2009.08.016. Epub 2009 Sep 18.

Martin F, Fedina A, Youshya S, Taylor GP. A 15-year prospective longitudinal study of disease progression in patients with HTLV-1 associated myelopathy in the UK. J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1336-40. doi: 10.1136/jnnp.2009.191239. Epub 2010 Jul 26.

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Principal Investigator

Referral Contact

For more information:

Steven Jacobson, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)

Joan M. Ohayon, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 5C442
(301) 496-3825

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010

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