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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

Summary

Number

15-N-0181

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

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Neurological Disorder

Recruitment Keyword(s)

None

Condition(s)

HTLV-1 Infection

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

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

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

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.

Objective:

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

Eligibility:

People ages 18 and older who:

Have HAM/TSP

Have finished screening under another protocol

Can walk 10 meters with or without walking sticks

Design:

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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Eligibility

INCLUSION CRITERIA:

-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

EXCLUSION CRITERIA:

-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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Citations:

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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Contacts:

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
10 CENTER DR
BETHESDA MD 20814
(301) 496-3825
eatonj@ninds.nih.gov

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
PRPL@cc.nih.gov

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