Status:
WITHDRAWN
High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy
Lead Sponsor:
Stony Brook University
Conditions:
Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary endpoint of this study is to determine what percentage of patients receiving high-dose Cyclophosphamide may experience a halt in the worsening of their disease or experience improvement of...
Detailed Description
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a common and under-recognized peripheral neuropathy that is thought to be immune-mediated. Randomized, placebo controlled clinical trials in...
Eligibility Criteria
Inclusion
- Diagnosis of CIDP according to the American Academy of Neurology clinical and electrophysiologic criteria
- Age \>18 but \< 75 years
- Modified Rankin Scale score of \>3 after two standard treatment regimens
- Patient must have a left ventricular ejection fraction of \>45%
- Serum Creatinine \<3mg/dL
- Willingness to participate in a clinical trial
Exclusion
- Patients who are preterminal or moribund
- Patients with active malignancies
- Patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome
- Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
- Pregnant women and breast-feeding women
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01236456
Start Date
October 1 2003
End Date
November 1 2006
Last Update
November 9 2021
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