Status:
COMPLETED
Rituximab to Treat Stiff Person Syndrome
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stiff Person Syndrome
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief Summary
This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle spasms induced b...
Detailed Description
This study will examine the safety, tolerability, and efficacy of the humanized monoclonal antibody Rituximab to induce a clinical and serological remission in patients with Stiff Person Syndrome (SPS...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Stiff Person Syndrome with elevated anti-GAD antibody titers.
- Between 25 to 80 years of age.
- Willingness to stop IVIg therapy 6 weeks prior to Rituximab/Placebo treatment and for the remainder of the study. \[If receiving IVIg, patients will be allowed to receive the ongoing non-immunosuppressive drugs used to treat SPS including Diazepam, Neurontin or Baclofen. The dose of these drugs will remain stable throughout the study and unchanged for 6 weeks prior to enrollment.\]
- Willingness and legal ability to give and sign informed study consent.
- Willingness to travel to NIH for scheduled protocol studies and treatment.
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- Adequate bone marrow, renal, and liver function: ANC greater than 1000/mm(3), BUN/Cr in normal range for age.
- Patients with Diabetes (Type II) will be allowed to participate because up to 40% of SPS patients have Diabetes.
- Patients with a history of controlled epilepsy will be allowed to participate because up to 5% of SPS patients have mild epilepsy which is easily controlled.
- EXCLUSION CRITERIA:
- Immunosuppressive drug therapy for SPS at the time of or 6 weeks prior to enrollment and for the remainder of the study. Specifically, candidates may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive.
- Any medical or social condition that precludes follow-up visits.
- Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are treated prior to enrollment.
- History of a coagulopathy or patients requiring anticoagulation.
- Any history of cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Patients with cardiomyopathy grade III or IV by the New York Heart Classification will be excluded from this study.
- Systemic edema or pulmonary edema.
- Chronic and severe symptomatic hypotension (SBP less than 100 mmHg).
- Chronic liver disease or alcoholism.
- Any condition, including active infections, that would likely increase the risk of protocol participation or confuse the understanding of the data.
- Pregnancy. Serum pregnancy test will be performed and must be negative in all women of childbearing potential enrolled in the study.
- History of active psychiatric disorder that may interfere with participation in the study.
- LABORATORY EXCLUSION CRITERIA (AT SCREENING):
- Hemoglobin: less than 7.0 gm/dL.
- Platelets: less than 100,000/mm.
- AST or ALT greater than 2.5 x Upper Limit of Normal unless related to primary disease.
- Positive Hepatitis B or C serology (Hep Surface antigen and Hep C hepatitis C antibody).
- Positive HIV.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00091897
Start Date
September 1 2004
End Date
May 1 2009
Last Update
August 31 2011
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892