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NCT00001778 · ClinicalTrials.gov registry record
Evaluation of Patients With HAM/TSP
A clinical trial of HTLV-I Infection and Tropical Spastic Paraparesis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- 750
- Enrollment target
- 1
- Study location
NCT00001778: Recruiting study of HTLV-I Infection and Tropical Spastic Paraparesis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00001778 is a study of HTLV-I Infection and Tropical Spastic Paraparesis that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 750 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001778, a study of HTLV-I Infection and Tropical Spastic Paraparesis, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- 750 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP. Study Population: Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate. Design and Outcome Measures: A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup.
Primary Outcome
To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 1998-04-06 |
What NCT00001778 shows while recruiting
NCT00001778 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with HTLV-I Infection appearing as the primary indexed condition, and to 0 interventions.
NCT00001778 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001778 about?
NCT00001778 is a clinical study titled "Evaluation of Patients With HAM/TSP". Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clini...
What is the current status of trial NCT00001778?
This trial is currently recruiting. The enrollment target is 750 participants. The study started on 1998-04-06.
What conditions does trial NCT00001778 study?
This clinical trial studies the following conditions: HTLV-I Infection, Tropical Spastic Paraparesis.
Who is sponsoring clinical trial NCT00001778?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001778 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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