Condition category
Nervous System Diseases
Date applied
27/03/2010
Date assigned
09/04/2010
Last edited
09/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yanqing Feng

ORCID ID

Contact details

Department of Neurology
Sun Yat-sen University
Zhongshan 2 Road 58
Guangzhou
510080
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Antituberculosis treatment in incomplete transverse myelitis in steroid-refractory patients: a prospective open label study

Acronym

ATT in myelitis

Study hypothesis

Incomplete transverse myelitis (ITM) of unknown origin is associated with high rates of morbidity and mortality, and treatment options for these patients are few. This pilot study was undertaken to determine whether antituberculous treatment (ATT) might help in patients with ITM whose condition continued to worsen despite receiving steroid treatment.

Ethics approval

Ethics Committee of the First Affiliated Hospital of Sun Yat-Sen University approved in June 2003

Study design

Prospective open-label pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Incomplete transverse myelitis (ITM)

Intervention

Prior to ATT initiation, all treatments with corticosteroids and other systemic immunosuppression therapy were discontinued. Our treatment protocols consisted of three antituberculous drugs regimen (isoniazid, rifampicin and pyrazinamide were used for 9 months), followed by a combination of isoniazid and rifampicin until 24 months. The dose of isoniazid was 8 mg/kg/day, rifampicin was 10 mg/kg/day, and pyrazinamide 25 mg/kg/day. Treatment was under our extensive observation. All patients had the following weekly liver function tests for the first one month of therapy and subsequently every 3 monthly: serum bilirubin, serum transaminases (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) and alkaline phosphatase. All patients were followed up for at least 1 year after treatment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Isoniazid, rifampicin, pyrazinamide

Primary outcome measures

Before the start of the assigned treatment all patients had a baseline visit, at which the medical history was obtained, and physical and neurological examinations were undertaken. The American Spinal Injury Association (ASIA) standards were adopted to assess subjects' neurological status. We used the ASIA Impairment Scale to evaluate sensory and motor function and neurological level. Activities of daily living (ADL) were assessed by Barthel Index (BI) (0 - 100 scale, with lower scores denoting less independence in activities of daily living); mobility were scored by the Hauser Ambulation Index.

Secondary outcome measures

1. Changes in quality of life, measured by the ASIA, BI and AI at baseline and at 12 months
2. MRI changes assessed at baseline and at 12 months

Each patient was followed up and assessed by the same physician during the study.

Overall trial start date

01/01/2003

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Development of sensory, motor, or autonomic dysfunction attributable to the spinal cord
2. Varying degrees of motor, sensory and sphincter dysfunction (though not necessarily symmetrical), but without complete paraplegia
3. Exclusion of extra-axial compressive aetiology by magnetic resonance imaging (MRI)
4. Worsened condition despite at least one 5-day course of intravenous (IV) methylprednisolone (0.5 - 1 g/d)
5. Cerebrospinal fluid mycobacterium tuberculosis (CSF MTB) culture were negative, with cell count less than 50/mm^3 and total protein less than 1.5 g/L
6. Aged 18 - 70 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

67 participants

Participant exclusion criteria

1. Sudden onset
2. History of previous radiation to the spine within the last 10 years
3. Central nervous system (CNS) manifestations of syphilis, Lyme disease, human immunodeficiency virus (HIV) infection
4. Clear arterial distribution clinical deficit consistent with thrombosis of the anterior spinal artery
5. History of clinically apparent optic neuritis
6. Brain MRI abnormalities suggestive of multiple sclerosis (MS) and clinically definite MS
7. Serologic or clinical evidence of connective tissue disease (sarcoidosis, Behcet's disease, Sjögren's syndrome, systematic lupus erythematosis [SLE], mixed connective tissue disorder, etc)

Recruitment start date

01/01/2003

Recruitment end date

01/06/2009

Locations

Countries of recruitment

China

Trial participating centre

Department of Neurology
Guangzhou
510080
China

Sponsor information

Organisation

Sun Yat-sen University (China)

Sponsor details

c/o Yanqing Feng
Department of Neurology
Zhongshan 2 Road 58
Guangzhou
510080
China
fyqgz@sina.com

Sponsor type

University/education

Website

http://www.sysu.edu.cn/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes