Status:
COMPLETED
Intravenous Immunoglobulin (IVIg) for the Treatment of Stiff-Man Syndrome (SMS)
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Muscle Rigidity
Spasm
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Stiff-man Syndrome (SMS) is a chronic, progressive disorder of the nervous system. It is associated with painful muscle spasms and rigidity involving muscles of the limbs, trunk, and neck. The cause o...
Detailed Description
Stiff-man Syndrome (SMS) is a chronic, disabling neurological disorder characterized by severe and painful axial and limb rigidity enhanced by anxiety, sudden motion or external stimuli. Although the ...
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.
Key Trial Info
Start Date :
April 1 1996
Trial Type :
INTERVENTIONAL
End Date :
May 1 2002
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00001550
Start Date
April 1 1996
End Date
May 1 2002
Last Update
July 14 2006
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892