Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT01867320
Eligibility Criteria:
* INCLUSION CRITERIA:
* 18 years or older
* Diagnosis of HAM/TSP as defined by WHO criteria, including a positive HTLV-1 EIA and confirmatory Western Blot.
* Patient must be willing and able to comply with all the aspects of trial design and follow-up.
* Patients must be able to provide informed consent
* If able to become pregnant or to father a child, agreeing to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy) for the duration of treatment arm of the study
EXCLUSION CRITERIA:
* Alternative diagnoses that can explain neurological disability
* Clinically significant medical disorders that, in the judgment of the investigators might expose the patient to undue risk of harm confound study outcomes or prevent the patient from completing the study. Examples of such conditions include but are not limited to poorly controlled cardiopulmonary conditions such as congestive heart failure, asthma or uncontrolled hypertension.
* Patient has received immunomodulatory/immunosuppressive therapy (including steroids) in the preceding 6 months.
* Patient with known myopathy or risk factors for CK elevation including being on other drugs known to cause myopathy or rhabdomyolysis.
* Pregnant or lactating women.
* Patient has received other investigational drugs within 6 months before enrollment
* Positive serological evidence of HIV, HTLV-II, Hepatitis B or C.
* Abnormal screening/baseline blood tests exceeding any of the limits defined below:
* Serum alanine transaminase (ALT) or aspartate transaminase (AST) levels greater than 3 times the upper limit of normal values; total bilirubin \> 2.0mg/dl; Serum amylase or lipase levels greater than twice the upper limit of normal values; serum creatine phosphokinase (CK) level exceeding 3 xULN and confirmed on repeat testing in 2 weeks.
* Platelet count \< 75,000/mm(3)
* Serum creatinine level \> 2.0 mg/dl
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01867320
Study Brief:
Protocol Section:
NCT01867320