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:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT00001550
Eligibility Criteria:
Men and non-pregnant women, between 18-75 years of age, who meet a defined criteria for the diagnosis of Stiff-man syndrome (SMS) will be screened as inpatients or in the outpatient clinic.
If the diagnosis is confirmed, the patients will be enrolled into the protocol, provided their disease remains symptomatic and poorly responsive to benzodiazepines.
Only patients with anti-GAD antibodies will be included.
Patients who have not received IVIg in the past 6 months may be included.
No pregnant or nursing women (confirmed by a pregnancy screening test).
No critically ill patients, such as those with severe cardiomyopathy, and respiratory insufficiency and severely incapacitated patients that require help for self care.
No patients with severe renal or hepatic disease, COPD or severe coronary artery disease.
No patients with serum IgA level less than 11 mg/dl.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001550
Study Brief:
Protocol Section:
NCT00001550